🔍 RecallPedia

lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

Class I - Dangerous
🏥 Medical Devices Recalled: December 19, 2014 SpineFrontier Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
  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:
SpineFrontier, Inc.
Reason for Recall:
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

Product Codes/Lot Numbers:

Lot/Serial Numbers: 06440-0000, 06441-0000, AG24

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0977-2015

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