Double Offset Rasp Handle — Class II medical device recall Z-2216-2014
Terminated recall by Zimmer, Inc., reported 2014-08-20, distributed nationwide. The firm received complaints for failure of the handle to remain assembled to the rasp during use due to vario
| Recall number | Z-2216-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-07-23 |
| Classified | 2014-08-14 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2015-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, FR, IT |
| Quantity | 412 units |
| Reason classes | device malfunction |
| Lot numbers | 97005188, 97005789 |
| Model numbers | 82016757821 |
Product
Double Offset Rasp Handle, Left Hand Nonsterile
Reason for recall
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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-2216-2014. 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.