🔍 RecallPedia

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

Class I - Dangerous
🏥 Medical Devices Recalled: January 3, 2014 Medtronic Sofamor Danek USA Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    TI13J01811
  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:
Medtronic Sofamor Danek USA Inc
Reason for Recall:
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

Product Codes/Lot Numbers:

TI13J01811

Distribution:

Distributed in: US, CA, NC, TX, IN, NJ, MI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0866-2014

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