Femoral Resurfacing Cup — Class II medical device recall Z-1498-2024
Ongoing recall by Synovo Production, reported 2024-04-17, distributed nationwide. Medical device components were marketed without FDA clearance
| Recall number | Z-1498-2024 |
|---|---|
| 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 | 496 units |
| UPC / GTIN / UDI-DI | 00814193025654, 00814193025661, 00814193025678, 00814193025685, 00814193025692, 00814193025708, 00814193025753 |
| Lot numbers | 01-03-0044, 01-03-0045, 01-03-0047, 01-03-0049, 01-03-0051, 01-03-0052, 01030044K2NN656, 01030044K3NN736, 01030045LNN657, 01030045MNN670, 01030045N1NN694, 01030045NNN694, 01030045QNN733, 01030045RNN742, 01030047L4NN662, 01030047LNN657, 01030047MNN674, 01030047N1NN689, 01030047NNN689, 01030047QNN733, 01030049M8NN670, 01030049MNN662, 01030049NNN736, 01030049QNN687, 01030049R1NN724, 01030049RNN725, 01030049UNN732, 01030049UNN733, 01030051K3NN658, 01030051K4NN666, 01030051K4NN667, 01030051KNN673, 01030051LNN685, 01030051M1NN694, 01030051M3NN694, 01030051M4NN697, 01030051MNN694, 01030051N1NN732, 01030051N1NN733, 01030051NNN731 and 10 more |
| Model numbers | 00814193025708/01-03-0042 |
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 for recall
Medical device components were marketed without FDA clearance
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-1498-2024. 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.