Xl por st 25.5x220mm, bowed\, bowed, 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 intramedullary rod fixation implants and accessories used in knee, hip, and nail procedures. The implants, identified by item number 00992125533 with lot numbers expiring before March 2027, were recalled because they were packaged in two different package configurations that failed packaging design verification tests. A total of 9,867 units were affected and distributed worldwide, including throughout the United States and in countries such as Canada, Australia, Japan, Brazil, and many others.
The recall affects the sterility and integrity of the implant packaging, which could potentially compromise the sterile condition of the devices prior to use. The product recall notice does not specify a remedy or corrective action that affected consumers should take.
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: 00992125533, 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.