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Synovo Production recalls Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 0
Recalled April 17, 2024 · FDA recall Z-1498-2024 · Synovo Production
Hazard
Medical device components were marketed without FDA clearance · FDA Class II
Units
496 units
Sold at
US Nationwide distribution in the state of WA.
Description
Medical device components were marketed without FDA clearance
Product
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
Manufacturer(s)
Synovo Production
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →