PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 17, 2018 Initiated: August 13, 2018 #Z-0092-2019

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.

Details

Recalling Firm
Stryker Spine
Units Affected
5
Distribution
US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR
Location
Allendale, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Spine. Units affected: 5.
Why was this product recalled?
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 17, 2018. Severity: Moderate. Recall number: Z-0092-2019.