Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Recall
- Recall Number
- Z-1226-2019
- Event Number
- 82587
- Firm
- DePuy Spine, Inc.
- FEI Number
- 1526439
- Product Code
- MAX
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 8, 2019
- Posted
- April 27, 2019
- Terminated
- January 12, 2023
- Address
- 325 Paramount Dr, Raynham, MA, 02767-5199
Description
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
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).
US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
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