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FDA (Device enforcement)Recalled 2017-02-28closedclass ii

Zimmer Biomet, Inc.: Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Is my product affected?

Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

  • UPC 00225750014

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet initiated a field action on February 28, 2017, for approximately 9,867 sterile-packaged Fem IM Nail implants (14mm diameter, 50cm length, right side) and related accessories. The implants were packaged in two different package configurations and were recalled due to packaging design verification test failures. The affected implants have item number 00225750014 with lot numbers expiring before March 2027, and were distributed worldwide including throughout the United States and to numerous countries in South America, Europe, Asia, and the Middle East.

The record does not specify a remedy or what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Details from the source

Reason for recall: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Distribution: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand Quantity: 9867 Lot/code info: Item Number:00225750014, Lot Number Expiry Date Before: March 2027

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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