🔍 RecallPedia

Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

Class I - Dangerous
🏥 Medical Devices Recalled: November 30, 2023 Waldemar Link GmbH & Co. KG (Mfg Site) Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI :04026575245253 Lot / Serial Number: C306165
  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:
Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

Product Codes/Lot Numbers:

UDI-DI :04026575245253 Lot / Serial Number: C306165

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0749-2024

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