DePuy Synthes various orthopedic instruments modified by U — Class II medical device recall Z-2317-2017
Terminated recall by DePuy Orthopaedics, Inc., reported 2017-06-14, distributed nationwide. Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k
| Recall number | Z-2317-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-01-06 |
| Classified | 2017-06-08 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2019-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 345 |
Product
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Reason for recall
Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
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-2317-2017. 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.