Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a… — Class II medical device recall Z-2396-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-08-17, distributed nationwide. Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
| Recall number | Z-2396-2016 |
|---|---|
| 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 | 2016-07-01 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 241 units |
| Reason classes | device malfunction |
| Model numbers | 0930-9-003 |
Product
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
Reason for recall
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
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-2396-2016. 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.