Recall Z-1225-2019 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
DePuy Spine, Inc.
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
| Date | Apr 27, 2019 (initiated Apr 8, 2019) |
| Status | Terminated |
| 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. Fo |
| Quantity | 3166 total |
| Distribution | US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171425 | CONCORDE LIFT Medos International SARL, Jul 20, 2017 |