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DePuy Spine, Inc. recalls Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate Sys
Recalled December 30, 2015 · FDA recall Z-0454-2016 · DePuy Spine
Hazard
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 · FDA Class II
Units
16 devices
Sold at
US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
Description
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
Product
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Manufacturer(s)
DePuy Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →