Zimmer Biomet, Inc.: Segmental fluted stem, 18x250mm bwd, Sterile,

Is my product affected?

Segmental fluted stem, 18x250mm bwd, Sterile,

• UPC 00585205418

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged segmental fluted stem implants (18x250mm) due to packaging design verification test failures. The affected implants were packaged in two different package configurations. A total of 9,867 units with item number 00585205418 and lot numbers expiring before July 2026 were distributed worldwide, including throughout the United States and in countries such as Canada, Australia, Japan, Brazil, and many others.

The record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 00585205418, Lot Number Expiry Date Before: July 2026

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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