Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A
  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:
DePuy Orthopaedics, Inc.
Reason for Recall:
Potential for Intra-operative breakage of driver tips
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

Product Codes/Lot Numbers:

Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0849-2018

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