Recall Z-0092-2019— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2018-08-13, terminated 2019-05-23. It names one FDA 510(k) clearance: K151726. 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.. Reason: The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-13
- Terminated
- 2019-05-23
- Firm location
- Allendale, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.