U.S. Recalls in September 2018

September 2018 recalls — page 7

These records include useful source details for the selected month.

2018 archive →

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 11 mm x 440 mm, Item Number: 814511440 recall — FDA Z-3130-2018

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 280 mm, Item Number: 814313280 recall — FDA Z-3068-2018

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

Vascular Technology VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref recall — FDA Z-3026-2018

Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver

Class IIFDA: TerminatedVascular Technology, Inc.

Medical DeviceSep 19, 2018

SPS Sterilization Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding recall — FDA Z-3036-2018

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

Micro Therapeutics Inc., Dba Ev3 Neurovascular ev3 TurboHawk PERPHERAL PLAQUE EXCISION recall — FDA Z-3022-2018

The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised…

Class IIFDA: TerminatedMicro Therapeutics Inc., Dba Ev3 Neurovascular

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.

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.

U.S. Recalls — September 2018

September 2018 recalls — page 7

How to use this monthly recall archive