Segmental fluted stem, 19x250mm bwd, 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 segmental fluted stem implants (19x250mm, used for knee, hip, and nail fixation) due to failures in packaging design verification testing. The affected implants were packaged in two different package configurations. Approximately 9,867 units with item number 00585205419 and lot numbers expiring before July 2026 were distributed worldwide, including throughout the United States and to numerous countries in Central and South America, Europe, Asia, the Middle East, and other regions.
The source document does not specify a remedy or what actions 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: 00585205419, Lot Number Expiry Date Before: July 2026
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.