CONMED Corp — Federal Records

FDA Recall: ConMed Corporation — Class II 20210505

Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may requi | Product: KIT_INFINITY_BASE Custom Procedural Ki...

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FDA Device Recall: KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial 2021-05-05

Class II — Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical...

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FDA Device Recall: INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial E 2021-05-05

Class II — Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical...

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FDA Device Recall: Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic proce 2020-12-30

Class II — Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

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FDA Device Recall: Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic proce 2020-12-30

Class II — Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

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FDA Recall: Conmed Corporation — Class II 20190515

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | Product: ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: T...

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FDA Device Recall: ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS 2019-05-15

Class II — Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

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FDA Device Recall: ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS 2019-05-15

Class II — Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

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FDA Device Recall: ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Numb 2019-05-15

Class II — Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

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FDA Device Recall: ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS 2019-05-15

Class II — Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

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FDA Recall: ConMed Corporation — Class II 20180307

Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. | Product: STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets ...

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FDA Device Recall: MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Conne 2018-04-04

Class II — Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

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FDA Device Recall: MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF 2018-04-04

Class II — Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

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FDA Device Recall: MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF 2018-04-04

Class II — Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

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FDA Device Recall: MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Numb 2018-04-04

Class II — Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

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FDA Device Recall: STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administrati 2018-03-07

Class II — Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.

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FDA Recall: ConMed Corporation — Class II 20171220

Manufactured with the incorrect anchor outer body | Product: Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical p

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FDA Recall: ConMed Corporation — Class II 20170419

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Ha | Product: HYFRECATOR 2000 HANDPIECE SHEATH, REF/...

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FDA Device Recall: Nonabsorbable suture anchor system intended to reattach soft tissue to bone in o 2017-12-20

Class II — Manufactured with the incorrect anchor outer body

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FDA Device Recall: HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Si 2017-04-19

Class II — For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were la...

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FDA Device Recall: Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages cont 2017-04-19

Class II — For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were la...

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FDA Device Recall: Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages cont 2017-04-19

Class II — For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were la...

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FDA Device Recall: Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages cont 2017-04-19

Class II — For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were la...

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FDA Recall: ConMed Corporation — Class II 20161026

The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | Product: CORE¿ Suction Irrigation Handpiece with 5mm x 32c...

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FDA Device Recall: CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solut 2016-10-26

Class II — The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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FDA Device Recall: CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catal 2016-10-26

Class II — The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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FDA Device Recall: CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solut 2016-10-26

Class II — The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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FDA Device Recall: CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, C 2016-10-26

Class II — The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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FDA Device Recall: CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bag 2016-10-26

Class II — The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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FDA Device Recall: Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) 2016-08-31

Class II — A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

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FDA Device Recall: Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3 2016-08-31

Class II — A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

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FDA Device Recall: Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, C 2016-08-31

Class II — A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

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FDA Device Recall: Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher P 2016-08-31

Class II — A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

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FDA Device Recall: Hip Preservation System Signature Series PreBent Burs under the following labels 2016-06-08

Class II — Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which ...

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FDA Recall: ConMed Corporation — Class I 20141210

Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The | Product: ADULT Radiotransparent Electrode, REF/...

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FDA Recall: ConMed Corporation — Class I 20141210

Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The | Product: MINI PEDIATRIC Radiotransparent Electr...

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FDA Recall: ConMed Corporation — Class I 20141210

Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The | Product: CONMED PEDIATRIC R2 Multifunction Elec...

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FDA Device Recall: ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARAB 2014-12-10

Class I — Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a dela...

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FDA Device Recall: MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- 2014-12-10

Class I — Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a dela...

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FDA Device Recall: CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Dire 2014-12-10

Class I — Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a dela...

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FDA Device Recall: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPAR 2014-12-10

Class I — Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a dela...

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FDA Device Recall: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPA 2014-12-10

Class I — Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a dela...

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FDA Device Recall: Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 1 2014-06-25

Class II — ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.

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FDA Device Recall: MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The d 2014-06-11

Class II — ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.

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FDA Recall: ConMed Corporation — Class II 20130130

ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal wa | Product: UltraClean(R) Accessory Electrode 6 in...

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FDA Recall: ConMed Corporation — Class II 20130130

ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal wa | Product: UltraClean(R) Accessory Electrode 6 in...

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FDA Recall: ConMed Corporation — Class II 20130130

ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal wa | Product: UltraClean(R) Accessory Electrode 4 in...

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FDA Device Recall: PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M 2013-05-22

Class II — ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potent...

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FDA Device Recall: ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, D 2013-02-27

Class II — Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

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FDA Device Recall: ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disp 2013-02-27

Class II — Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

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FDA Device Recall: UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, 2013-01-30