🔍 RecallPedia

Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.

Class I - Dangerous
🏥 Medical Devices Recalled: December 7, 2015 Innovasis Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
  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:
Innovasis, Inc
Reason for Recall:
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.

Product Codes/Lot Numbers:

Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502

Distribution:

Distributed in: US, CA, KS, OH, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0662-2016

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