FDAMay 30, 2023device

ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

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

The hazard

Medical device components were marketed without FDA clearance and without FDA approval

What to do

FDA enforcement status: Ongoing

Brands named

synovo productionsynovo

UPCs

00814193025807008141930258140081419302582100814193025838008141930258450081419302585200814193025869

Recall history

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

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →