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

Zimmer Biomet, Inc.: Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Is my product affected?

Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

  • UPC 00784302008

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, affecting 9,867 sterile-packaged intramedullary rod implants and accessories used in knee, hip, and nail procedures. The implants were packaged in two different package configurations and failed packaging design verification tests. The affected product has item number 00784302008 with lot numbers expiring before July 2026, and was distributed worldwide across numerous countries including the United States, Canada, and many other nations.

The recall notice 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: 00784302008, Lot Number Expiry Date Before: July 2026

Source

Official record: FDA (Device enforcement) ↗

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

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