Class II
Medical Device Recall: 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
Synovo Production · May 30, 2023
Reason for Recall
Medical device components were marketed without FDA clearance and without FDA approval
Distribution
US Nationwide distribution in the state of WA.
States Affected
NATIONWIDE
Quantity Affected
764 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1496-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.