Concorde Lift, Expandable Interbody Device, spinal fusion… recallZ-1225-2019 · DePuy Spine, Inc. · initiated Apr 8, 2019
Class II Terminated All recalls posted in April 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-1225-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 8, 2019
- Posted by the FDA
- Apr 27, 2019
- Recalling firm
- DePuy Spine, Inc.
- Quantity
- 3166 total
- Product code
- MAX
- FDA submissions
- K171425
- Distribution
- US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Product description
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Code information (models, lots, serial numbers)
All lots
Other devices under the same FDA submission
6 devices cleared under K171425 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CONCORDE LIFT 1978-09-021CMedos International Sàrl · Intervertebral fusion device with bone graft, lumbar23 reports
- CONCORDE LIFT 1978-09-023LMedos International Sàrl · Intervertebral fusion device with bone graft, lumbar14 reports
- CONCORDE LIFT 1978-09-026CMedos International Sàrl · Intervertebral fusion device with bone graft, lumbar3 reports
- CONCORDE LIFT 1978-11-023LMedos International Sàrl · Intervertebral fusion device with bone graft, lumbar3 reports
- CONCORDE LIFT 1978-11-021CMedos International Sàrl · Intervertebral fusion device with bone graft, lumbar1 report
- CONCORDE LIFT 1978-11-027LMedos International Sàrl · Intervertebral fusion device with bone graft, lumbar1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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