FDA Device recall Z-2317-2017
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
- FDA Device
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures by Depuy Orthopaedics, citing 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 devic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2317-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-06 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Reason
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.
Identifiers
| code_info | Unknown |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2317-2017%22
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