DePuy Spine, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0454-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 20, 2015

Date Posted: December 30, 2015

Recall Number: Z-0454-2016

Event ID: 72654

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

Status: Terminated

Product Quantity: 16 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated