Device product
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Z-2187-2013
Product summary
- Firm
- Spine Wave, Inc.
- Event
- Event 65968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-2187-2013
Official wording
Reason: A component Superior endplate manufactured from a different polymer than specified
Code information: Lot Numbers: 272L08 and 272L09
Distribution pattern: Distributed in the states of FL and OR.
Derived failure modes
-
Unknown
A component Superior endplate manufactured from a different polymer than specified