Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate Syst

FDA device recall Z-0454-2016 · posted 2015-12-21 · Terminated

Recall details

Recalling firm

DePuy Spine, Inc.

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

Action taken

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 within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any product listed below has been forwarded to another facility, contact that facility and provide them with this letter. 5. Keep a copy of this notice. For further questions please call (508) 828-3774

Root cause

Device Design

Status

Terminated

Product code

KWQ

Quantity affected

16 devices

Distribution

US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.

Date initiated

2015-11-20

Date posted

2015-12-21

Date terminated

2017-07-03

Location

Raynham, MA