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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall MODEL: Aegis Torque Handle CATALOG NO. : 287110800 see related information
Date Initiated by Firm November 20, 2015
Date Posted December 21, 2015
Recall Status1 Terminated 3 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 2		 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.
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