DePuy Spine, Inc. recalls Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate Sys…

Recall date

November 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0454-2016

FDA classification

Class II

Brand / firm

DePuy Spine, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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