Fem IM Nail 15mmdx44cm, 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 approximately 9,867 sterile-packaged Fem IM Nail 15mm diameter by 44cm implants and related accessories used for knee, hip, and nail fixation procedures. The recall affects implants with item number 00225244015 and lot numbers expiring before March 2027. The products were distributed worldwide, including throughout the United States and in numerous countries across Europe, Latin America, Asia, the Middle East, and other regions.
The recall was issued because the implants were packaged in two different package configurations that failed packaging design verification testing. The sterility or integrity of the packaging could not be verified to meet required standards. The recall notice does not specify a remedy for affected consumers or healthcare facilities.
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: 00225244015, 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.