FDA Device recall Z-0454-2016
Aegis Torque Handle CATALOG NO. : 2871-10-800
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Aegis Torque Handle CATALOG NO. : 2871-10-800 by Depuy Spine, citing 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 accou….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0454-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-20 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Spine |
| Distribution | CA, CO, FL, ID, MD, MI, NC, NY, TX |
Product
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
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
Identifiers
| code_info | LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0454-2016%22
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