RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical… — Class II medical device recall Z-1357-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2015-04-08, distributed nationwide. This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is
| Recall number | Z-1357-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-02-23 |
| Classified | 2015-03-31 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | IE, IL |
| Quantity | 54 of |
| Reason classes | foreign material, device malfunction |
| UPC / GTIN / UDI-DI | 10603295156192 |
| Model numbers | 2975-00-920 |
Product
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Reason for recall
This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
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-1357-2015. 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.