Class II
Medical Device Recall: 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
Synovo Production · May 30, 2023
Reason for Recall
Medical device components were marketed without FDA clearance
Distribution
US Nationwide distribution in the state of WA.
States Affected
NATIONWIDE
Quantity Affected
496 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1498-2024
Status: ongoing
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