FDAMay 30, 2023device

Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052

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

00814193025708008141930256780081419302569200814193025685008141930256540081419302566100814193025753

Recall history

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

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