Class II — DePuy Spine, Inc.
| Recalling firm | DePuy Spine, Inc. |
|---|---|
| Registered facility | DEPUY SPINE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Device does not mate as intended. |
| Product | EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 |
| Quantity | 183 devices |
| Distribution | US: PA and OUS: SE, BE, IT, PT |
| Initiated | 2015-04-21 |
| Classified | 2015-05-26 |
| Terminated | 2018-10-03 |
| Recall number | Z-1674-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Spine, Inc. (Z-1674-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71067/
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