Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Concorde Lift Expandable Interbody Device

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Concorde Lift Expandable Interbody Device see related information
Date Initiated by Firm April 08, 2019
Date Posted April 27, 2019
Recall Status1 Terminated 3 on January 12, 2023
Recall Number Z-1225-2019
Recall Event ID 82587
510(K)Number K171425  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Code Information All lots
Recalling Firm/
Manufacturer		 DePuy Spine, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact Stephanie Koenig
574-371-4584
Manufacturer Reason
for Recall		 A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 4/8/19, the firm distributed Medical Device Recall letters to its customers. The letter recommended that surgeons use alternative implants. In addition, customers were asked to immediately case use of the affected devices and to return all affected implants on hand. In addition, customers were asked to complete and return the business reply form. Customers were asked to notify surgeon users and others in the facility who need to be informed of the recall. If any affected product was forwarded to another facility, please immediately contact that facility to communicate the field action. For product-related questions, please contact your local DePuy Synthes Spine Sales Consultant. For questions about device recall information provided, please contact Stephanie Koenig, Recall Associate, at 574 371-4584 (M-F; 8 a.m.  5 p.m. EST).
Quantity in Commerce 3166 total
Distribution US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
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
-
-