FDA recall Z-0092-2019

Stryker Spine · Class II · 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.

Reason for recall

The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.

Distribution

US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR

Key facts

Status
Terminated
Initiation date
2018-08-13
Report date
2018-10-17
Termination date
2019-05-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2019