Concorde Lift Driver Shaft AO — Class II medical device recall Z-0848-2018
Terminated recall by DePuy Orthopaedics, Inc., reported 2018-03-14, distributed nationwide. Potential for Intra-operative breakage of driver tips
| Recall number | Z-0848-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Raynham, MA, United States |
| Recall initiated | 2017-07-26 |
| Classified | 2018-03-02 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 130 units |
| Reason classes | device malfunction |
| Lot numbers | 052316-AR, 121416-AR |
Product
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Reason for recall
Potential for Intra-operative breakage of driver tips
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-0848-2018. 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.