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

Zimmer Biomet, Inc.: Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Is my product affected?

Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

  • UPC 00225748004

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

What happened

Zimmer Biomet Inc. initiated a field action on February 28, 2017 for Fem IM Nail 14mm diameter 48cm left sterile implants and accessories due to packaging design verification test failures. The affected implants were packaged in two different package configurations. A total of 9,867 units were distributed worldwide, including throughout the United States and in numerous countries internationally. The affected product has item number 00225748004 with lot numbers expiring before March 2027.

The recall notice does not specify a remedy or any instructions for affected consumers to follow.

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:00225748004, 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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