Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
FDA Recall Z-1225-2019 · Posted 2019-04-27
Recalling FirmDePuy Spine, Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2019-04-08
Date Terminated2023-01-12
Product Quantity3166 total
Reason for Recall
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
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).
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.