Reported Oct 17, 2018 · Terminated

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

Stryker Spine

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611

Is this the product you have?

  • AVS Aria Cage
  • Catalog Number 48753212 Product UsageThe 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
Lot codes and dates
  • Lot Number 7HX
Amount recalled
5

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 23, 2019 · Data as of Sep 19, 4:56 PM UTC

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