FDA Medical Device Recalls (openFDA)
DePuy Spine, Inc.: Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
- Recall number
- Z-1225-2019
- Recalling firm
- DePuy Spine, Inc.
- Product
- Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
- Status
- Terminated
- Initiated
- 2019-04-08
- Posted
- 2019-04-27
- Terminated
- 2023-01-12
- Reason
- A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
- Root cause
- 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
- 3166 total
- Distribution
- US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K171425"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 1526439
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28