FDA-Device2015-12-30Class II
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
DePuy Spine, Inc.
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
Sold states
US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
Affected count
16 devices
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0454-2016Don't want to check this manually?
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