Zimmer Biomet, Inc.: 4.5 BROAD SCP PLT 26-H STER

Is my product affected?

4.5 BROAD SCP PLT 26-H STER

• UPC 47494502601

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

What happened

Zimmer Biomet is recalling 87 sterile-packaged implants (model 4.5 Broad SCP Plt 26-H) due to failures identified during packaging design verification testing. The implants were distributed domestically across all U.S. states and Puerto Rico, as well as internationally to multiple countries including Canada, Australia, Japan, and others.

The record does not specify a remedy or corrective action for consumers who may have affected implants.

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

Hazard

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

Details from the source

Reason for recall: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Distribution: Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON Quantity: 87 Lot/code info: 510K: K101073,P,K113224 Item Numbers: 47494502601

Source

Official record: FDA (Device enforcement) ↗

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

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