🔍 RecallPedia

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Class I - Dangerous
🏥 Medical Devices Recalled: July 12, 2023 Medtronic Sofamor Danek USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200
  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 Laser Marking - Solera Awl Tip Tap
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Product Codes/Lot Numbers:

SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2363-2023

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