RecallRadar

FDA Device recall Z-0454-2016

Aegis Torque Handle CATALOG NO. : 2871-10-800

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

AgencyFDA Device
Recall numberZ-0454-2016
ClassificationClass II
Statusterminated
Initiated2015-11-20
Published2015-12-30
Last updated2026-09-13 11:53 UTC
CompanyDepuy Spine
DistributionCA, 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_infoLOT 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.