🔍 RecallPedia

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

Class I - Dangerous
🏥 Medical Devices Recalled: February 16, 2023 Medtronic Sofamor Danek USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN 00643169554696, Lot/Batch numbers: H5806345
  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:
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

Product Codes/Lot Numbers:

GTIN 00643169554696, Lot/Batch numbers: H5806345

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1413-2023

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