Z-0092-2019 Class II Terminated
FDA device recall Z-0092-2019 was initiated by Stryker Spine on August 13, 2018 and is designated Class II. Reason for recall: The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. The recall status is terminated (terminated May 23, 2019). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- August 13, 2018
- Termination Date
- May 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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.
Distribution Pattern
US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR
Code Information
Lot Number 7HX