🔍 RecallPedia

Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights, and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.

Class I - Dangerous
🏥 Medical Devices Recalled: July 7, 2014 Stryker Spine Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Stryker Spine
Reason for Recall:
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights, and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.

Product Codes/Lot Numbers:

Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2627-2014

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