🔍 RecallPedia

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument

Class I - Dangerous
🏥 Medical Devices Recalled: March 30, 2022 restor3d Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
  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:
restor3d Inc.
Reason for Recall:
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument

Product Codes/Lot Numbers:

Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1026-2022

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