Stryker Spine recalls AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral bo…

Recall date

August 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0092-2019

FDA classification

Class II

Brand / firm

Stryker Spine

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.