Device product
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Z-1226-2019
Product summary
- Event
- Event 82587
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3166 total
- Official record key
device-enforcement:Z-1226-2019
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.