Z-0454-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- November 20, 2015
- Termination Date
- July 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 devices
Product Description
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
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
Distribution Pattern
US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
Code Information
LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134