Recall Z-1498-2024— Synovo Production
Class II · Ongoing
Class II FDA medical device recall by Synovo Production, initiated 2023-05-30. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Medical device components were marketed without FDA clearance.
- Recalling firm
- Synovo Production
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-30
- Firm location
- Fullerton, CA, United States
Product description
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
Reason for recall
Medical device components were marketed without FDA clearance
Data sourced from openFDA. This site is unofficial and independent of the FDA.