fda
28 records
FDA Device Recall: Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilizati
2022-07-06
Class II — Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or ...
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FDA Device Recall: Everest MI XT Inner Dilator, Catalog Number 5101-90167
2022-03-09
Class II — Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and fr...
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FDA Device Recall: Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
2021-10-20
Class II — Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal o...
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FDA Device Recall: Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2
2021-06-09
Class II — Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
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FDA Device Recall: Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2
2021-06-09
Class II — Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
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FDA Device Recall: Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct provid
2021-04-21
Class II — Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and sp...
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FDA Device Recall: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of Y
2021-02-03
Class II — The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
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FDA Recall: K2M, Inc — Class II
20200527
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip brea | Product: K2M, ALEUTIAN Interbody Spacer Systems...
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FDA Recall: K2M, Inc — Class II
20200527
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip brea | Product: K2M, ALEUTIAN Interbody Spacer Systems...
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FDA Device Recall: Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break
2020-12-16
Class II — All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle crack...
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FDA Device Recall: Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The An
2020-12-09
Class II — Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surg...
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel
2020-05-27
Class II — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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FDA Device Recall: K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick
2019-10-16
Class II — Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M prod...
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FDA Device Recall: YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5
2019-10-16
Class II — Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective...
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irs_exempt
2 records
nppes
1 records
ny_corps
1 records
NY Corp: K2M, LLC
2007-01-19
DOMESTIC LIMITED LIABILITY COMPANY | County: Suffolk | Jurisdiction: New York
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