Recall Z-1496-2024— 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: 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. Reason: Medical device components were marketed without FDA clearance and without FDA approval.
- Recalling firm
- Synovo Production
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-30
- Firm location
- Fullerton, CA, United States
Product description
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
Reason for recall
Medical device components were marketed without FDA clearance and without FDA approval
Data sourced from openFDA. This site is unofficial and independent of the FDA.