🔍 RecallPedia

Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

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

What Should You Do?

  1. Check if you have this product:
    E2S47525 Lot 1301 and E2S47535 Lot 1301
  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 is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
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 Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

Product Codes/Lot Numbers:

E2S47525 Lot 1301 and E2S47535 Lot 1301

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2067-2014

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