Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1361

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

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 400 mm, Item Number: 814311400 recall — FDA Z-3062-2018

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 440 mm, Item Number: 814509440 recall — FDA Z-3118-2018

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 340 mm, Item Number: 814611340 recall — FDA Z-3156-2018

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 260 mm, Item Number: 814511260 recall — FDA Z-3121-2018

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

Diagnostica Stago STA N¿oplastine CI Plus, 10 ml vial recall — FDA Z-2993-2018

QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

Class IIFDA: TerminatedDiagnostica Stago, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number: 814311440 recall — FDA Z-3064-2018

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 340 mm, Item Number: 814509340 recall — FDA Z-3113-2018

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 420 mm, Item Number: 814609420 recall — FDA Z-3151-2018

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 280 mm, Item Number: 814409280 recall — FDA Z-3079-2018

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.

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 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 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 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 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

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

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

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

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

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 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 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 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 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.

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