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FDA (Device enforcement)Recalled 2017-02-28closedclass ii

Zimmer Biomet, Inc.: Por fullct fem st 18x200mm, Sterile,

Is my product affected?

Por fullct fem st 18x200mm, Sterile,

  • UPC 00784301808

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 implants (Por fullct fem st 18x200mm) due to packaging design verification test failures. The affected implants were packaged in two different package configurations and distributed worldwide, including throughout the United States and numerous international locations. Approximately 9,867 units with Item Number 00784301808 and lot numbers expiring before July 2026 were involved in this action.

The source document does not specify what actions affected consumers or healthcare providers should take regarding this recall.

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: 00784301808, 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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