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U.S. Department of Health and Human Services

Class 2 Device Recall Concorde Lift

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  Class 2 Device Recall Concorde Lift see related information
Date Initiated by Firm July 26, 2017
Create Date March 02, 2018
Recall Status1 Terminated 3 on April 03, 2019
Recall Number Z-0848-2018
Recall Event ID 79072
510(K)Number K171425  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Concorde Lift Driver Shaft AO.

Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Code Information Product code: 287804101G Lot number: 052316-A R, 121416-A R 
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact Christina Corbett
508-880-8100
Manufacturer Reason
for Recall		 Potential for Intra-operative breakage of driver tips
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 1, 2017, an Urgent Product Recall notice titled "CONCORDE LIFT DRIVER Driver Shaft and Torque Handle" was mailed to customers that received the affected instruments. The letter described the issue, potential hazard, and actions to be taken. The notice instructs customers to cease further distribution or use and to contact a DePuy Synthes Spine sales consultant to return the products subject to recall. Customers are to review, complete, sign, and return the business reply form provided to the firm within 5 business days of receipt of the notification. A copy of the notice should be forwarded to all staff that need to be informed, as well as, any facility that the affected device was further distributed to. Customers should direct any questions regarding this recall to their DePuy Synthes Spine Sales Consultant or the Clarke Madigan, DePuy Synthes Spine Recall Coordinator, at 508-828-609 or DPYUS-SpineFieldActions@its.jnj.com.
Quantity in Commerce 130 units total
Distribution Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = Medos International, SARL
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