🔍 RecallPedia

PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Class I - Dangerous
🏥 Medical Devices Recalled: May 15, 2020 TeDan Surgical Innovations Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Code: DS-0014 UDI Number: 00851797006450 Lot Number: 2018020801 2018061101
  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:
TeDan Surgical Innovations LLC
Reason for Recall:
Lack of pouch seal. Product is labelled as sterile.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Product Codes/Lot Numbers:

Product Code: DS-0014 UDI Number: 00851797006450 Lot Number: 2018020801 2018061101

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2527-2020

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