FDA-Device2024-04-17Class II
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
Hazard
Medical device components were marketed without FDA clearance
Sold states
US Nationwide distribution in the state of WA.
Affected count
496 units
Manufactured in
1501 N Harbor Blvd Ste 209, N/A, Fullerton, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1498-2024Don't want to check this manually?
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