| Class 2 Device Recall Concorde Lift | |
Date Initiated by Firm | April 08, 2019 |
Date Posted | April 27, 2019 |
Recall Status1 |
Terminated 3 on January 12, 2023 |
Recall Number | Z-1226-2019 |
Recall Event ID |
82587 |
510(K)Number | K152156 K160464 |
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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Product | Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L) |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
DePuy Spine, Inc. 325 Paramount Dr Raynham MA 02767-5199
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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 |
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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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510(K) Database | 510(K)s with Product Code = MAX
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