Aegis Torque Handle CATALOG NO — Class II medical device recall Z-0454-2016
Terminated recall by DePuy Spine, Inc., reported 2015-12-30, distributed in CA, CO, FL, ID, MD, MI, NC, NY…. Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with
| Recall number | Z-0454-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Spine, Inc., Raynham, MA, United States |
| Recall initiated | 2015-11-20 |
| Classified | 2015-12-21 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-07-03 |
| Distributed | CA, CO, FL, ID, MD, MI, NC, NY, TX |
| Quantity | 16 devices |
| Lot numbers | GB0707, GB0906, GB0907, GB58815, GB59244, GB61134 |
| Model numbers | 2871-10-800 |
Product
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Reason for recall
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
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-0454-2016. 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.