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

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

Is my product affected?

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

  • UPC 00225750004

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 by 50cm left sterile implants due to packaging design verification test failures. The affected implants were packaged in two different package configurations. Approximately 9,867 units with item number 00225750004 and lot expiry dates before March 2027 were distributed worldwide, including throughout the United States and internationally to countries such as Canada, Australia, Japan, Brazil, and many others.

The recall record does not specify a remedy for affected consumers.

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:00225750004, 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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