ACETABULAR FIXATION CUP — Class II medical device recall Z-1496-2024
Ongoing recall by Synovo Production, reported 2024-04-17, distributed nationwide. Medical device components were marketed without FDA clearance and without FDA approval
| Recall number | Z-1496-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synovo Production, Fullerton, CA, United States |
| Recall initiated | 2023-05-30 |
| Classified | 2024-04-08 |
| Reported by FDA | 2024-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 764 units |
| UPC / GTIN / UDI-DI | 00814193025807, 00814193025814, 00814193025821, 00814193025838, 00814193025845, 00814193025852, 00814193025869 |
| Lot numbers | 01-01-0562, 01-01-0564, 01-01-0566, 01010556E1NN726, 01010556E1NN727, 01010562H1NN732, 01010562HNN733, 01010562J1NN745, 01010564C3NN658, 01010564CNN656, 01010564CNN659, 01010564D1NN681, 01010564DNN671, 01010564E2NN698, 01010564ENN697, 01010564FNN733, 01010564G1NN744, 01010564GNN746, 01010566BNN670, 01010566BNN671, 01010566BNN688, 01010566BNN689, 01010566CNN663, 01010566DNN699 |
| Model numbers | 00814193025807/01-01-0554, 00814193025814/01-01-0556, 00814193025821/01-01-0558, 00814193025838/01-01-0560, 00814193025845/01-01-0562, 00814193025852/01-01-0564, 00814193025869/01-01-0566 |
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 for recall
Medical device components were marketed without FDA clearance and without FDA approval
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1496-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.