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Synovo Production recalls ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0
Recalled April 17, 2024 · FDA recall Z-1496-2024 · Synovo Production
Hazard
Medical device components were marketed without FDA clearance and without FDA approval · FDA Class II
Units
764 units
Sold at
US Nationwide distribution in the state of WA.
Description
Medical device components were marketed without FDA clearance and without FDA approval
Product
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
Manufacturer(s)
Synovo Production
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →