Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for Fem IM Nail sterile-packaged implants due to packaging design verification test failures. The affected devices were packaged in two different package configurations. A total of 9,867 units with item number 00225238016 and lot numbers expiring before March 2027 were distributed worldwide, including throughout the United States and numerous countries in the Americas, Europe, Asia, and the Middle East.
The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 00225238016, Lot Number Expiry Date Before: March 2027
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.