co_sos
1 records
courtlistener_docket
2 records
Miller v. Smith & Nephew Inc
2026-05-28
Federal docket 2:26-cv-00961 (wied); matched party 'Smith & Nephew Inc'
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Kuykendall v. Smith & Nephew Inc
2026-03-31
Federal docket 3:26-cv-01015 (txnd); matched party 'Smith & Nephew Inc'
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EPA (Environmental Protection Agency)
2 records
epa_echo
2 records
fda
214 records
FDA Recall: Smith & Nephew, Inc. — Class II
20251224
Removal of affected lot of screws due to labeling error. | Product: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
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FDA Device Recall: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
2025-12-24
Class II — Removal of affected lot of screws due to labeling error.
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FDA Device Recall: META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
2025-05-28
Class II — Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with an...
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FDA Device Recall: BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
2024-12-11
Class II — Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
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FDA Device Recall: Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D.
2024-11-13
Class II — The Bipolar assembly contains an oversized Retainer Ring.
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FDA Device Recall: smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT
2024-11-06
Class II — Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
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FDA Device Recall: smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SI
2024-11-06
Class II — Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the produ...
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FDA Device Recall: smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5
2024-11-06
Class II — Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the produ...
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FDA Device Recall: ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation o
2024-09-18
Class II — Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
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FDA Device Recall: smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Steril
2024-06-05
Class II — Packaging contained the incorrect size of femoral head from what was displayed on the label.
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FDA Recall: Smith & Nephew, Inc. — Class II
20230426
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM ins | Product: JOURNEY II UNI XLPE TIBIA INSERT MEDIA...
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FDA Device Recall: JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262;
2023-11-01
Class II — The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was las...
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FDA Device Recall: smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZ
2023-09-27
Class II — The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as describe...
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FDA Device Recall: TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647
2023-08-30
Class II — A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL ...
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FDA Device Recall: Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Num
2023-06-07
Class II — Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential sign...
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FDA Device Recall: Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, P
2023-06-07
Class II — Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential sig...
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FDA Device Recall: Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Num
2023-06-07
Class II — Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential sign...
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FDA Device Recall: JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
2023-04-26
Class II — A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert...
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FDA Device Recall: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2)
2022-07-27
Class II — The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
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FDA Device Recall: Acufex Access Advanced Positioning Kit - indicated for use to position and distr
2022-02-16
Class II — Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
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FDA Device Recall: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
2021-12-22
Class II — Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released ...
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FDA Device Recall: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
2021-12-22
Class II — Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released ...
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FDA Device Recall: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
2021-12-22
Class II — Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released ...
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FDA Device Recall: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x
2021-11-24
Class II — The labels on the packages of screws were switched.
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FDA Device Recall: 6.5MMX165MM CANNULATED SCREW
2021-10-27
Class II — The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
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FDA Device Recall: LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Lef
2021-06-30
Class II — The device components experienced a manufacturing process error that resulted in surface damage from product handling.
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FDA Device Recall: VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Num
2021-02-10
Class II — Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
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FDA Recall: Smith & Nephew, Inc. — Class II
20201104
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in | Product: 5.5MM Arthrogarde Hip Access Cannula
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FDA Recall: Smith & Nephew, Inc. — Class II
20201028
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by th | Product: OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Abs...
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FDA Recall: Smith & Nephew, Inc. — Class II
20201028
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by th | Product: TWINFIX 5.0MM AB SUTURE ANCHOR WITH T...
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FDA Recall: Smith & Nephew, Inc. — Class II
20201028
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by th | Product: TWINFIX 5.0MM AB SUTURE ANCHOR WITH TW...
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FDA Recall: Smith & Nephew, Inc. — Class II
20201028
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by th | Product: TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES...
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FDA Recall: Smith & Nephew, Inc. — Class II
20200819
The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. | Product: PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for a...
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FDA Recall: Smith & Nephew, Inc. — Class II
20200617
A manufacturing error resulted in out of specification R3 Acetabular Shells | Product: smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the follow
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FDA Device Recall: 5.5MM Arthrogarde Hip Access Cannula
2020-11-04
Class II — The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
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FDA Device Recall: OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 722
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Num
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Num
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 7220216
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number:
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number:
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number:
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 721071
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number:
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Numbe
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Num
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Num
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Num
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Numb
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Numbe
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number:
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Numb
2020-10-28
Class II — Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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FDA Device Recall: EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicate
2020-09-16
Class II — Multiple or incorrect expiration dates were provided on the affected designation labels.
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FDA Device Recall: Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surger
2020-08-26
Class II — The products were improperly heat treated.
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FDA Device Recall: PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage:
2020-08-19
Class II — The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
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FDA Device Recall: SUTUREFIX ULTRA Suture, Product number 72203855
2020-08-12
Class II — A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
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FDA Device Recall: Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: i
2020-08-05
Class II — The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
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FDA Device Recall: TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance f
2020-07-29
Class II — A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
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FDA Device Recall: smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufa
2020-06-17
Class II — A manufacturing error resulted in out of specification R3 Acetabular Shells
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FDA Device Recall: smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the
2020-06-17
Class II — A manufacturing error resulted in out of specification R3 Acetabular Shells
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FDA Device Recall: smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in
2020-06-17
Class II — A manufacturing error resulted in out of specification R3 Acetabular Shells
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FDA Device Recall: smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufac
2020-06-17
Class II — A manufacturing error resulted in out of specification R3 Acetabular Shells
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FDA Device Recall: smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufa
2020-06-17
Class II — A manufacturing error resulted in out of specification R3 Acetabular Shells
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FDA Device Recall: JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage:
2020-06-03
Class II — The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
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FDA Device Recall: JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage:
2020-06-03
Class II — The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
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FDA Device Recall: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
2020-04-29
Class II — Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create...
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FDA Device Recall: NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue P
2020-04-08
Class II — Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
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FDA Device Recall: TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended t
2020-02-26
Class II — Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to ...
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FDA Device Recall: LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, R
2020-02-05
Class II — Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
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FDA Recall: Smith & Nephew, Inc. — Class II
20190918
The affected products were inadvertently packaged with an incorrect screw component. | Product: LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage
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FDA Recall: Smith & Nephew, Inc. — Class II
20190403
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | Product: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibia...
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FDA Device Recall: smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX
2019-12-25
Class II — There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occu...
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FDA Device Recall: LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN Inter
2019-11-20
Class II — LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not ...
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FDA Device Recall: LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423
2019-09-18
Class II — The affected products were inadvertently packaged with an incorrect screw component.
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FDA Device Recall: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY I
2019-04-03
Class II — Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
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FDA Device Recall: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY I
2019-04-03
Class II — Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
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FDA Device Recall: smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE,
2019-03-27
Class II — Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
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FDA Device Recall: smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZ
2019-03-27
Class II — Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
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FDA Device Recall: SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
2019-01-23
Class II — The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
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FDA Recall: Smith & Nephew, Inc. — Class II
20180829
Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left. | Product: GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONEN...
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FDA Recall: Smith & Nephew, Inc. — Class II
20180418
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over toleranc | Product: D-RAD Self-Tapping Locking Screw inten...
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FDA Recall: Smith & Nephew, Inc. — Class II
20180131
Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa | Product: smith&nephew Mini-Fragment Plating System, VLP(R...
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FDA Device Recall: JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 7402311
2018-10-10
Class II — The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that t...
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FDA Device Recall: JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 7402111
2018-10-10
Class II — The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that t...
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FDA Device Recall: Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211,
2018-10-10
Class II — The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that t...
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FDA Device Recall: GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71
2018-08-29
Class II — Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
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FDA Device Recall: Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74
2018-06-27
Class II — The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient In...
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FDA Device Recall: Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size
2018-06-27
Class II — The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient In...
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FDA Device Recall: smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
2018-06-20
Class II — One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
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FDA Device Recall: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF
2018-05-30
Class II — The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
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FDA Device Recall: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, RE
2018-05-30
Class II — The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
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FDA Device Recall: Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
2018-05-02
Class II — Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistribu...
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FDA Device Recall: D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involvin
2018-04-18
Class II — One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-...
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FDA Device Recall: smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating Sy
2018-01-31
Class II — Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
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FDA Device Recall: smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72
2018-01-31
Class II — One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
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FDA Device Recall: Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
2018-01-31
Class II — The expiration date provided on the label is incorrect.
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FDA Device Recall: Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401.
2018-01-31
Class II — In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the pr...
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FDA Device Recall: smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating Sy
2018-01-31
Class II — Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
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FDA Recall: Smith & Nephew, Inc. — Class II
20170510
The stability data does not support the product labeled with a 10-year shelf life. | Product: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
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FDA Recall: Smith & Nephew, Inc. — Class II
20170510
The stability data does not support the product labeled with a 10-year shelf life. | Product: RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
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FDA Recall: Smith & Nephew, Inc. — Class II
20170426
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. | Product: D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following si...
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FDA Recall: Smith & Nephew, Inc. — Class II
20170301
The single use devices are provided sterile and do not have an expiration date on the label. | Product: Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
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FDA Recall: Smith & Nephew, Inc. — Class II
20170301
The single use devices are provided sterile and do not have an expiration date on the label. | Product: Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
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FDA Recall: Smith & Nephew, Inc. — Class II
20170125
Lack of 510k clearance for design modification. | Product: Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only.
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FDA Device Recall: smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degree
2017-11-22
Class II — A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
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FDA Device Recall: smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDG
2017-11-22
Class II — The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
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FDA Device Recall: smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus a
2017-09-06
Class II — The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
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FDA Device Recall: LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, I
2017-07-05
Class II — The incorrect Loctite adhesive was used to assemble the impactor heads.
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FDA Device Recall: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY:
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY:
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY:
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY:
2017-05-10
Class II — The stability data does not support the product labeled with a 10-year shelf life.
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FDA Device Recall: D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a
2017-04-26
Class II — The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
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FDA Device Recall: Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, RE
2017-04-26
Class II — The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 T
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 Th
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 Th
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 T
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
2017-04-26
Class II — The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 Th
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthop
2017-04-26
Class II — The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
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FDA Device Recall: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 Th
2017-04-26
Class II — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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FDA Device Recall: Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
2017-03-01
Class II — The single use devices are provided sterile and do not have an expiration date on the label.
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FDA Device Recall: Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
2017-03-01
Class II — The single use devices are provided sterile and do not have an expiration date on the label.
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FDA Device Recall: Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
2017-03-01
Class II — The single use devices are provided sterile and do not have an expiration date on the label.
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FDA Device Recall: Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
2017-03-01
Class II — The single use devices are provided sterile and do not have an expiration date on the label.
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FDA Device Recall: Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
2017-03-01
Class II — The single use devices are provided sterile and do not have an expiration date on the label.
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FDA Device Recall: Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
2017-03-01
Class II — The single use devices are provided sterile and do not have an expiration date on the label.
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FDA Device Recall: Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply
2017-01-25
Class II — Lack of 510k clearance for design modification.
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FDA Device Recall: REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nep
2017-01-18
Class II — The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
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FDA Device Recall: Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indic
2017-01-11
Class II — All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
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FDA Device Recall: Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip
2017-01-11
Class II — All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
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FDA Recall: Smith & Nephew, Inc. — Class II
20161109
Some Bipolar shells were manufactured with an out of specification retainer groove. | Product: TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 7132204
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FDA Recall: Smith & Nephew, Inc. — Class II
20160928
Sterility seal integrity failures on the Renasys Sterile Transparent Film | Product: RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile
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FDA Recall: Smith & Nephew, Inc. — Class II
20160803
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw. | Product: SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1),...
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FDA Recall: Smith & Nephew, Inc. — Class II
20160427
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Inse | Product: TC-PLUS(TM), Primary Fixed Tibial Comp...
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FDA Device Recall: TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 7132204
2016-11-09
Class II — Some Bipolar shells were manufactured with an out of specification retainer groove.
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FDA Device Recall: TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71
2016-11-09
Class II — Some Bipolar shells were manufactured with an out of specification retainer groove.
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FDA Device Recall: RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains
2016-09-28
Class II — Sterility seal integrity failures on the Renasys Sterile Transparent Film
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FDA Device Recall: SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), ST
2016-08-03
Class II — The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
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FDA Device Recall: Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417
2016-07-27
Class II — The device could be subject to breaches of its sterile packaging.
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FDA Device Recall: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375
2016-07-06
Class II — The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
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FDA Device Recall: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 7142137
2016-07-06
Class II — The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
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FDA Device Recall: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 7142137
2016-07-06
Class II — The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
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FDA Device Recall: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 714213
2016-07-06
Class II — The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, RE
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, RE
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R,
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, RE
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R,
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R,
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, R
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R,
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R,
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R,
2016-04-27
Class II — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base pla...
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FDA Device Recall: Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND,
2016-01-13
Class II — One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-dr...
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FDA Recall: Smith & Nephew, Inc. — Class II
20151216
The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates | Product: Smith & Nephew PERI-LOC VOLAR DISTAL R...
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FDA Recall: Smith & Nephew, Inc. — Class II
20150916
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. | Product: Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMOR...
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FDA Recall: Smith & Nephew, Inc. — Class II
20150701
Sterility of device maybe compromised | Product: ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
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FDA Recall: Smith & Nephew, Inc. — Class II
20150617
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. | Product: R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LI...
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FDA Device Recall: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT
2015-12-16
Class II — The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left...
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FDA Device Recall: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT -
2015-12-16
Class II — The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left...
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FDA Device Recall: Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only,
2015-09-16
Class II — The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
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FDA Device Recall: ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended
2015-07-01
Class II — Sterility of device maybe compromised
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FDA Device Recall: R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE
2015-06-17
Class II — The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
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FDA Device Recall: R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE
2015-06-17
Class II — The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
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FDA Device Recall: R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE
2015-06-17
Class II — The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
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FDA Recall: Smith & Nephew, Inc. — Class II
20141015
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Product: RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS...
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FDA Recall: Smith & Nephew Inc — Class II
20140528
A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Product: TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 ...
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FDA Recall: Smith & Nephew Inc — Class II
20140305
Inner spherical radius of the shell is undersized. | Product: Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc.
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FDA Device Recall: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY
2014-12-17
Class II — The stem taper on this device is undersized; the gauge point is not deep enough.
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FDA Device Recall: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1
2014-12-17
Class II — The stem taper on this device is undersized; the gauge point is not deep enough.
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FDA Device Recall: RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: R
2014-10-15
Class II — RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
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FDA Device Recall: RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: R
2014-10-15
Class II — RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
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FDA Device Recall: RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product
2014-10-15
Class II — RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
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FDA Device Recall: RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patien
2014-10-01
Class II — Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
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FDA Device Recall: TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R
2014-08-27
Class II — There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.
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FDA Device Recall: TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 7
2014-05-28
Class II — A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
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FDA Device Recall: TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT,
2014-05-28
Class II — A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
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FDA Device Recall: Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 668009
2014-03-19
Class II — Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port seali...
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FDA Device Recall: Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing
2014-03-19
Class II — Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port seali...
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FDA Device Recall: Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 6
2014-03-19
Class II — Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port seali...
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FDA Device Recall: Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66
2014-03-19
Class II — Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port seali...
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FDA Device Recall: Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 6
2014-03-19
Class II — Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port seali...
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FDA Device Recall: Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smi
2014-03-05
Class II — Inner spherical radius of the shell is undersized.
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FDA Device Recall: Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound
2014-03-05
Class II — Modification of the bacterial overflow guard (filter) and related changes to product labeling.
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FDA Device Recall: REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 O
2014-01-01
Class II — One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
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FDA Recall: Smith & Nephew Inc — Class II
20131211
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. | Product: GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, ...
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FDA Recall: Smith & Nephew Inc — Class II
20131113
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. | Product: GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage...
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FDA Device Recall: GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1),
2013-12-11
Class II — The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
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FDA Device Recall: GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 7
2013-12-11
Class II — The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
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FDA Device Recall: GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF
2013-12-11
Class II — The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
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FDA Device Recall: GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF
2013-12-11
Class II — The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
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FDA Device Recall: GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF
2013-12-11
Class II — The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
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FDA Device Recall: GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188.
2013-11-13
Class II — Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
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FDA Device Recall: GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168.
2013-11-13
Class II — Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
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FDA Device Recall: TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 716
2013-04-24
Class II — One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diamete...
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FDA Device Recall: INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTUR
2013-03-20
Class II — 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
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fda_adverse
1 records
FDA AE Manufacturer: SMITH & NEPHEW, INC
Drug adverse event reporter — Product: COLLAGENASE SANTYL
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lobbying
4 records
Lobbying Firm: SMITH & NEPHEW, INC.
Registered lobbying firm — Washington, DC — Manufacturer of medical devices and biologics
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Lobbying Client: SMITH & NEPHEW
Lobbied by CORNERSTONE GOVERNMENT AFFAIRS, INC. — Medical technology
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Lobbying Client: SMITH & NEPHEW
Lobbied by CORNERSTONE GOVERNMENT AFFAIRS, INC. — Medical technology
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nppes
1 records
ny_corps
1 records
NY Corp: SMITH & NEPHEW, INC.
1997-04-07
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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SEC EDGAR
1 records
sec_enforcement
1 records
Feb. 6, 2012 Smith & Nephew PLC
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sec_litigation
1 records
SEC Litigation: Smith & Nephew PLC
2012-02-06
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