ACETABULAR BEARING — Class II medical device recall Z-1497-2024
Ongoing recall by Synovo Production, reported 2024-04-17, distributed nationwide. Medical device components were marketed without FDA clearance
| Recall number | Z-1497-2024 |
|---|---|
| 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 | 1,681 units |
| UPC / GTIN / UDI-DI | 00814193025906, 00814193025913, 00814193025920, 00814193025937, 00814193025944, 00814193025951, 00814193025968 |
| Lot numbers | 01-02-4254, 01-02-4456, 01-02-4458, 01-02-4558, 01-02-4760, 01-02-4962, 01-02-5164, 01-02-5266, 01024254FNN612, 01024254FNN613, 01024254FNN620, 01024254FNN644, 01024254GNN614, 01024254GNN623, 01024254NN651, 01024254NN652, 01024254NN741, 01024456ENN613, 01024456ENN620, 01024456ENN644, 01024456ENN650, 01024456FNN614, 01024456FNN620, 01024456FNN623, 01024456FNN644, 01024456FNN650, 01024456NN651, 01024456NN652, 01024456NN656, 01024456NN728, 01024458NN651, 01024458NN652, 01024558FNN614, 01024558FNN623, 01024558HNN686, 01024558HNN692, 01024558JNN698, 01024558NN629, 01024760ENN616, 01024760ENN620 and 48 more |
| Model numbers | 00814193025906/01-02-4254 |
Product
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
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-1497-2024. 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.