🔍 RecallPedia

Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

Class I - Dangerous
🏥 Medical Devices Recalled: January 30, 2019 U&I Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021
  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:
U&I CORP.
Reason for Recall:
The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

Product Codes/Lot Numbers:

Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1823-2020

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