Recall Z-0454-2016 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
DePuy Spine, Inc.
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
| Date | Dec 21, 2015 (initiated Nov 20, 2015) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | DePuy sent an Urgent Voluntary Product Recall Notification dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to do the following: 1. Review inventory located within your facility and quarantine any products listed in this recall notice. Please contact your DePuy Synthes Spine* Sales Consultant to return any inventory located within your facility. 2. Review, complete, sign and return the attached business reply form to in accordance with the directions on the business reply form |
| Quantity | 16 devices |
| Distribution | US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.