Device product
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
Z-0092-2019
Product summary
- Firm
- Stryker Spine
- Event
- Event 80971
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0092-2019
Official wording
Reason: The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
Code information: Lot Number 7HX
Distribution pattern: US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR
Derived failure modes
-
Unknown
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.