Waldemar Link GmbH & Co. KG (Mfg Site): Link Patella Glide Resection Guide Recalled for Mislabeling and Surgical Risks

Agency Publication Date: January 18, 2024

Summary

Waldemar Link GmbH & Co. KG is recalling one unit of the Link Patella Glide Resection Guide, which is used during total knee replacement surgeries. The device is mislabeled as a 'Large' size, but it actually has the dimensions of a small/medium tool due to a manufacturing mix-up. This error could cause a surgeon to remove too little bone material during a procedure, preventing the implant from fitting correctly and extending the time a patient is under anesthesia. This specific guide is identified as Product Code 15-2530/05 and was distributed in New Hampshire.

Risk

The mislabeled dimensions mean the guide will not align correctly with the patient's anatomy during surgery. This can result in incorrect bone resection, causing the knee implant to fit poorly and requiring the surgeon to perform additional corrective steps, which increases the risk of surgical complications and longer operative time.

What You Should Do

Identify if you have the affected Link Patella Glide Resection Guide by checking the packaging for Product Code 15-2530/05 and Lot/Serial Number C306165.
Verify the Unique Device Identifier (UDI-DI) on the product label, which should match 04026575245253.
If you are a healthcare provider or hospital in possession of this specific lot, stop using the device immediately and quarantine it to prevent use in surgery.
Contact the manufacturer, Waldemar Link GmbH & Co. KG, or your local distributor to arrange for the return of the mislabeled device and to receive a correctly labeled replacement.
Patients who have recently undergone a total knee arthroplasty (Endo-Model Knee System) and have concerns about their recovery should contact their orthopedic surgeon or healthcare provider.
For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer/Healthcare contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Link Patella Glide Resection Guide (Endo-Model Knee System)

Model / REF:

15-2530/05

UPC Codes:

04026575245253

Lot Numbers:

C306165

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93662

Status: Active

Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)

Sold By: Specialty medical distributors

Manufactured In: Germany

Units Affected: 1 unit

Distributed To: New Hampshire

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if you have the affected Link Patella Glide Resection Guide by checking the packaging for Product Code 15-2530/05 and Lot/Serial Number C306165.

Verify the Unique Device Identifier (UDI-DI) on the product label, which should match 04026575245253.

If you are a healthcare provider or hospital in possession of this specific lot, stop using the device immediately and quarantine it to prevent use in surgery.

Contact the manufacturer, Waldemar Link GmbH & Co. KG, or your local distributor to arrange for the return of the mislabeled device and to receive a correctly labeled replacement.

Patients who have recently undergone a total knee arthroplasty (Endo-Model Knee System) and have concerns about their recovery should contact their orthopedic surgeon or healthcare provider.

For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.