2018 U.S. Recalls — FDA & NHTSA Archive

Monthly breakdown

2018 recalls by month

Select a month to review the recall records reported during that period.

2018 recalls — page 61

Records are ordered by the best available source date.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 460 mm, Item Number: 814313460 recall — FDA Z-3077-2018

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 380 mm, Item Number: 814513380 recall — FDA Z-3137-2018

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 380 mm, Item Number: 814313380 recall — FDA Z-3073-2018

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 260 mm, Item Number: 814509260 recall — FDA Z-3109-2018

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 Endoprosthesis Tracheobronchial Self-Expanding recall — FDA Z-3037-2018

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 125 13 mm x 360 mm, Item Number: 814313360 recall — FDA Z-3072-2018

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 340 mm, Item Number: 814413340 recall — FDA Z-3102-2018

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 280 mm, Item Number: 814611280 recall — FDA Z-3154-2018

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 460 mm, Item Number: 814311460 recall — FDA Z-3065-2018

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

Ortho-Clinical Diagnostics VITROS Chemistry Products Cl- Slides, Product Code 684 4471 recall — FDA Z-3044-2018

The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around…

Class IIIFDA: TerminatedOrtho-Clinical Diagnostics

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 13 mm x 360 mm, Item Number: 814613360 recall — FDA Z-3168-2018

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 380 mm, Item Number: 814511380 recall — FDA Z-3127-2018

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 320 mm, Item Number: 814313320 recall — FDA Z-3070-2018

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 320 mm, Item Number: 814609320 recall — FDA Z-3148-2018

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 Enteral Endoprosthesis Colonic/Duodenal Stent recall — FDA Z-3038-2018

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 320 mm, Item Number: 814411320 recall — FDA Z-3090-2018

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 380 mm, Item Number: 814411380 recall — FDA Z-3093-2018

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

NordicNeuroLab AS fMRI Hardware System VisualSystem allows video signals from the stimulus recall — FDA Z-3023-2018

Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).

Class IIFDA: TerminatedNordicNeuroLab AS

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number: 814413360 recall — FDA Z-3103-2018

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 420 mm, Item Number: 814611420 recall — FDA Z-3160-2018

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 380 mm, Item Number: 814613380 recall — FDA Z-3169-2018

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 280 mm, Item Number: 814513280 recall — FDA Z-3134-2018

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 400 mm, Item Number: 814613400 recall — FDA Z-3170-2018

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 440 mm, Item Number: 814613440 recall — FDA Z-3172-2018

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

Class IIFDA: TerminatedZimmer Biomet, Inc.

About the 2018 recall archive

This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.

U.S. Recalls in 2018

2018 recalls by month

2018 recalls — page 61

About the 2018 recall archive