Device product
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Z-1225-2019
Product summary
- Event
- Event 82587
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3166 total
- Official record key
device-enforcement:Z-1225-2019
Official wording
Reason: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Code information: All lots
Distribution pattern: US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.