FDA-Device2024-04-17Class II
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
Hazard
Medical device components were marketed without FDA clearance and without FDA approval
Sold states
US Nationwide distribution in the state of WA.
Affected count
764 units
Manufactured in
1501 N Harbor Blvd Ste 209, N/A, Fullerton, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1496-2024Don't want to check this manually?
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