Aegis Torque Handle recall
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Why was Aegis Torque Handle 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134
- Product
- Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
- Recalling firm
- DePuy Spine, Inc.
- Quantity
- 16 devices
- Distribution
- US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
- Recall date
- December 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)