Concorde Lift Torque Limiting Handle — Class II medical device recall Z-0849-2018
Terminated recall by DePuy Orthopaedics, Inc., reported 2018-03-14, distributed nationwide. Potential for Intra-operative breakage of driver tips
| Recall number | Z-0849-2018 |
|---|---|
| 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 | 041117A, 122315-AR, 122315-BR |
Product
Concorde Lift Torque Limiting Handle. Must be 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-0849-2018. 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.