Por fullct fem st 16x200mm, Sterile,
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 implants (specifically Por fullct fem st 16x200mm) due to packaging design verification test failures. The affected implants were packaged in two different package configurations and were distributed worldwide, including throughout the United States and numerous international locations. Approximately 9,867 units were involved in this action, identified by item number 00784301608 with lot expiry dates before July 2026.
The source document does not specify what consumers or healthcare providers should do in response to this field action.
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: 00784301608, 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.