Class 2 Device Recall MODEL: Aegis Torque Handle CATALOG NO. : 287110800

• Date Initiated by Firm: November 20, 2015
• Date Posted: December 21, 2015
• Recall Status: Terminated on July 03, 2017
• Recall Number: Z-0454-2016
• Recall Event ID: 72654
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• Product: Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
• Code Information: LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134
• Recalling Firm/ Manufacturer: DePuy Spine, Inc.; 325 Paramount Dr; Raynham MA 02767-5199
• For Additional Information Contact: Jamis Gamache; 508-828-3774
• Manufacturer 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
• FDA Determined 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 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
• Quantity in Commerce: 16 devices
• Distribution: US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.