FDAMay 30, 2023device

ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Medical device components were marketed without FDA clearance

What to do

FDA enforcement status: Ongoing

Brands named

synovo productionsynovo

UPCs

00814193025906008141930259130081419302592000814193025937008141930259680081419302594400814193025951

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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