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 | Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length |
| Product | Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. |
| Quantity | 16 devices |
| Distribution | US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY. |
| Initiated | 2015-11-20 |
| Classified | 2015-12-21 |
| Terminated | 2017-07-03 |
| Recall number | Z-0454-2016 |
| 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-0454-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72654/
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