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FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

27,110medical device recall records

2,329FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 795

27,110 detailed records are currently available in this category.

Medical DeviceSep 19, 2018

LeMaitre Vascular AnastoClip GC Closure System, REF# 4007-08 a closure system designed to recall — FDA Z-3042-2018

The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in…

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number: 814313260 recall — FDA Z-3067-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 11 mm x 320 mm, Item Number: 814611320 recall — FDA Z-3155-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number: 814511180 recall — FDA Z-3120-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 11 mm x 440 mm, Item Number: 814611440 recall — FDA Z-3161-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number: 814511400 recall — FDA Z-3128-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

SPS Sterilization Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial recall — FDA Z-3039-2018

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Class IIFDA: TerminatedSPS Sterilization, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 11 mm x 440 mm, Item Number: 814411440 recall — FDA Z-3096-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 9 mm x 380 mm, Item Number: 814409380 recall — FDA Z-3084-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 420 mm,Item Number: 814313420 recall — FDA Z-3075-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number: 814509320 recall — FDA Z-3112-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 380 mm, Item Number: 814413380 recall — FDA Z-3104-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 11 mm x 420 mm, Item Number: 814511420 recall — FDA Z-3129-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 13 mm x 460 mm, Item Number: 814613460 recall — FDA Z-3173-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 9 mm x 260 mm, Item Number: 814609260 recall — FDA Z-3146-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Ohio Medical Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC recall — FDA Z-2995-2018

The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of…

Class IIFDA: TerminatedOhio Medical Corporation

Medical DeviceSep 19, 2018

Intuitive Surgical da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 recall — FDA Z-3024-2018

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the…

Class IIFDA: OngoingIntuitive Surgical, Inc.

Medical DeviceSep 19, 2018

SPS Sterilization Vascular Solutions Venture Rx Catheter, 6F, resterilized recall — FDA Z-3041-2018

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Class IIFDA: TerminatedSPS Sterilization, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 11 mm x 420 mm, Item Number: 814411420 recall — FDA Z-3095-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 300 mm, Item Number: 814413300 recall — FDA Z-3100-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 9 mm x 280 mm, Item Number: 814609280 recall — FDA Z-3147-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 280 mm, Item Number: 814413280 recall — FDA Z-3099-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number: 814311420 recall — FDA Z-3063-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 13 mm x 320 mm, Item Number: 814613320 recall — FDA Z-3166-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.