Synthes 3 — Class II medical device recall Z-2265-2014
Terminated recall by Synthes, Inc., reported 2014-08-27, distributed in MI, WI. A screw set was returned from the field for destruction after being exposed to flood water, which was erroneou
| Recall number | Z-2265-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-06-30 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-12-18 |
| Distributed | MI, WI |
| Quantity | 4 |
| Lot numbers | EV01609 |
| Model numbers | 145.17E |
Product
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Reason for recall
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
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-2265-2014. 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.