🔍 RecallPedia

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

Class I - Dangerous
🏥 Medical Devices Recalled: October 20, 2022 CoreLink Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI M725AT32080, Lot Codes: SM135217, SM129260
  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:
CoreLink LLC
Reason for Recall:
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

Product Codes/Lot Numbers:

UDI/DI M725AT32080, Lot Codes: SM135217, SM129260

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0954-2023