Zimmer Biomet, Inc.: Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Is my product affected?

Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

• UPC 00585205416

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 knee joint implants (Item Number 00585205416) due to packaging design verification test failures. The affected implants were packaged in two different package configurations and have an expiry date before July 2026. Approximately 9,867 units were distributed worldwide across numerous countries including the United States, Canada, Australia, Japan, and many others.

The source document does not specify a remedy 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: 00585205416, 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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