Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica… — Class II medical device recall Z-1816-2012
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2012-06-27, distributed nationwide. Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fr
| Recall number | Z-1816-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2011-12-29 |
| Classified | 2012-06-15 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2013-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 41 units |
| Reason classes | device malfunction |
| Lot numbers | P5E93 |
| Model numbers | 1020-1400 |
Product
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
Reason for recall
Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
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-1816-2012. 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.