Zimmer Biomet, Inc.: Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Is my product affected?

Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

• UPC 00585205415

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 certain sterile-packaged knee joint implants (specifically segmental fluted stems measuring 15x250mm) due to packaging design verification test failures. The affected implants were packaged in two different package configurations. Approximately 9,867 units with item number 00585205415 and lot numbers expiring before March 2027 were distributed worldwide, including throughout the United States and numerous countries in Europe, Asia, South America, and the Middle East.

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: 00585205415, Lot Number Expiry Date Before: March 2027

Source

Official record: FDA (Device enforcement) ↗

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

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