Fem IM Nail 16mmdx42cm, 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 16mm diameter by 42cm sterile-packaged implants and related fixation accessories due to packaging design verification test failures. The affected implants were packaged in two different package configurations. A total of 9,867 units with item number 00225242016 and lot numbers expiring before March 2027 were distributed worldwide, including throughout the United States and to countries such as Canada, Australia, Japan, Brazil, Mexico, and many others.
The record does not specify a remedy for consumers who received or were implanted with these devices.
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: 00225242016, 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.