UOC Femoral Driver — Class II medical device recall Z-1692-2017
Terminated recall by United Orthopedic Corporation, reported 2017-04-05, distributed in CA. The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction
| Recall number | Z-1692-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Orthopedic Corporation, Hsinchu, Taiwan |
| Recall initiated | 2017-02-10 |
| Classified | 2017-03-29 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2017-06-28 |
| Distributed | CA |
| Countries outside the US | ES, PK, TW |
| Quantity | 33 units |
| Reason classes | device malfunction |
| Lot numbers | T16A178A |
Product
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Reason for recall
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
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-1692-2017. 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.