Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1359

The newest recall records with useful source details are listed here.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number: 814615360 recall — FDA Z-3174-2018

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 11 mm x 340 mm, Item Number: 814411340 recall — FDA Z-3091-2018

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 460 mm, Item Number: 814409460 recall — FDA Z-3088-2018

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 Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized recall — FDA Z-3033-2018

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 130 11 mm x 260 mm, Item Number: 814611260 recall — FDA Z-3153-2018

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 9 mm x 380 mm, Item Number: 814309380 recall — FDA Z-3051-2018

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 360 mm, Item Number: 814511360 recall — FDA Z-3126-2018

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

remel THIOGLYCOLLATE MEDIUM W/O IND recall — FDA Z-3017-2018

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Class IIFDA: TerminatedRemel Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number: 814511340 recall — FDA Z-3125-2018

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 13 mm x 300 mm, Item Number: 814513300 recall — FDA Z-3135-2018

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 15 mm x 440 mm, Item Number: 814515440 recall — FDA Z-3145-2018

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 400 mm, Item Number: 814509400 recall — FDA Z-3116-2018

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 9 mm x 180 mm, Item Number: 814509180 recall — FDA Z-3108-2018

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 13 mm x 260 mm, Item Number: 814513260 recall — FDA Z-3133-2018

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 Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized recall — FDA Z-3027-2018

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 Right 130 13 mm x 420 mm, Item Number: 814513420 recall — FDA Z-3139-2018

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 460 mm, Item Number: 814509460 recall — FDA Z-3119-2018

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 380 mm, Item Number: 814611380 recall — FDA Z-3158-2018

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 460 mm, Item Number: 814413460 recall — FDA Z-3107-2018

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 15 mm x 320 mm, Item Number: 814515320 recall — FDA Z-3142-2018

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 11 mm x 260 mm, Item Number: 814411260 recall — FDA Z-3089-2018

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 9 mm x 420 mm, Item Number: 814309420 recall — FDA Z-3052-2018

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 460 mm, Item Number: 814609460 recall — FDA Z-3152-2018

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 340 mm, Item Number: 814409340 recall — FDA Z-3082-2018

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

Class IIFDA: TerminatedZimmer Biomet, Inc.

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