Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Reported: December 30, 2015 Initiated: November 20, 2015 #Z-0454-2016
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
Details
- Recalling Firm
- DePuy Spine, Inc.
- Units Affected
- 16 devices
- Distribution
- US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.. Recalled by DePuy Spine, Inc.. Units affected: 16 devices.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0454-2016.
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