Fem IM Nail 16mmdx44cm, 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 sterile-packaged Fem IM Nail 16mm diameter by 44cm intramedullary rod implants and accessories due to packaging design verification test failures. The affected implants were packaged in two different package configurations and distributed worldwide, including throughout the United States and 29 other countries. Approximately 9,867 units with item number 00225244016 and lot numbers with expiry dates before March 2027 were involved.
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: 00225244016, 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.