🔍 RecallPedia

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

Class I - Dangerous
🏥 Medical Devices Recalled: September 26, 2019 Theralase Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332
  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:
Theralase Inc.
Reason for Recall:
Device was shipped without a Unique Device Identification (UDI) label.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

Product Codes/Lot Numbers:

Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0606-2020

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