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Recall Observatory FDA recall evidence

Device product

Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

Z-0454-2016

November 20, 2015

Class II

Product summary

Firm
DePuy Spine, Inc.
Event
Event 72654
Status
Terminated
Classification
Class II
Quantity
16 devices
Official record key
device-enforcement:Z-0454-2016

Official wording

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

Code information: LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134

Distribution pattern: US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Manufacturing error