🔍 RecallPedia

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21

Class I - Dangerous
🏥 Medical Devices Recalled: December 23, 2022 Waldemar Link GmbH & Co. KG (Mfg Site) Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04026575257393 Lot Number: 2123233
  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:
Waldemar Link GmbH & Co. KG (Mfg Site)
Reason for Recall:
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21

Product Codes/Lot Numbers:

UDI-DI: 04026575257393 Lot Number: 2123233

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2067-2023

Related Recalls