🔍 RecallPedia

ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height

Class I - Dangerous
🏥 Medical Devices Recalled: September 29, 2014 4-Web Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Model ASTS-LG1212 serial numbers: AL23BA064, AL23BA065, AL23BA066, AL23BA067, AL23BA068, AL23BA069, AL23BA070, AL23BA071, AL23BA072, AL23BA073, AL23BA074, AL23BA075, AL23BA076, AL23BA077, AL23BA078, AL23BA079, AL23BA080, AL23BA081, AL23BA082, AL23BA083, AL23BA084, AL23BA085, AL23BA086, AL23BA087, AL23BA088, AL23BA089, AL23BA090, AL23BA091, AL23BA092, AL23BA093 Model ASTS-LG0612 serial numbers: AL13BA050, AL13BA051, AL13BA052, AL13BA053, AL13BA054, AL13BA055, AL13BA056, AL13BA057, AL13BA058, AL13BA059, AL13BA060, AL13BA061, AL13BA062, AL13BA063, AL13BA064, AL13BA065, AL13BA066, AL13BA067, AL13BA068, AL13BA069, AL13BA070, AL13BA071, AL13BA072, AL13BA073, AL13BA074, AL13BA075, AL13BA076
  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:
4-Web Inc.
Reason for Recall:
Product is mislabeled.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height

Product Codes/Lot Numbers:

Model ASTS-LG1212 serial numbers: AL23BA064, AL23BA065, AL23BA066, AL23BA067, AL23BA068, AL23BA069, AL23BA070, AL23BA071, AL23BA072, AL23BA073, AL23BA074, AL23BA075, AL23BA076, AL23BA077, AL23BA078, AL23BA079, AL23BA080, AL23BA081, AL23BA082, AL23BA083, AL23BA084, AL23BA085, AL23BA086, AL23BA087, AL23BA088, AL23BA089, AL23BA090, AL23BA091, AL23BA092, AL23BA093 Model ASTS-LG0612 serial numbers: AL13BA050, AL13BA051, AL13BA052, AL13BA053, AL13BA054, AL13BA055, AL13BA056, AL13BA057, AL13BA058, AL13BA059, AL13BA060, AL13BA061, AL13BA062, AL13BA063, AL13BA064, AL13BA065, AL13BA066, AL13BA067, AL13BA068, AL13BA069, AL13BA070, AL13BA071, AL13BA072, AL13BA073, AL13BA074, AL13BA075, AL13BA076

Distribution:

Distributed in: US, TX, MT, DC, CA, IL, MD

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0812-2015