Zimmer Biomet, Inc.: Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Is my product affected?

Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

• UPC 00585205217

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 implants (17x190mm) 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 00585205217 and lot expiry dates before March 2027 were distributed worldwide, including throughout the United States and in 34 other countries spanning North America, South America, Europe, Asia, the Middle East, and Australia.

The source document does not specify what remedy affected consumers should pursue.

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: 00585205217, 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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