Z-1225-2019Class II

Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26...

Name: Z-1225-2019 Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26...
Creator: DePuy Spine, Inc.
Published: 2019-04-08
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2019-04-08 / Terminated

FDA source

DePuy Spine, Inc. began a recall of Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21... on 2019-04-08. FDA classified it as Class II and gives the reason as "A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1225-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-08
Posted: 2019-04-27
Terminated: 2023-01-12
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)
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
FDA 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 in commerce: 3166 total
Distribution: US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1225-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1225-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26
Z-1226-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26

Product code MAX

K171425Class IIConcorde LiftMedos International SARL / cleared 2017-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)