Fem IM Nail 16mmdx48cm, 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 initiated a field action on February 28, 2017, for sterile-packaged Fem IM Nail implants (16mm diameter, 48cm length) and accessories due to packaging design verification test failures. Approximately 9,867 units with item number 00225248016 and expiration dates before March 2027 were affected. These implants were distributed worldwide, including throughout the United States and in countries such as Canada, Mexico, Brazil, the United Kingdom, France, Germany, Japan, and Australia, among many others.
The packaging design verification test failures created a potential concern with how the implants were packaged in their sterile containers. The recall record does not specify what remedy consumers or healthcare facilities should undertake.
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:00225248016, 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.