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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

LINK BIO CORP: SymphoKnee Patella Sizing Template Recalled for Incorrect Labeling

Agency Publication Date: July 25, 2024
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Summary

LINK BIO CORP is recalling 8 units of the LINK SymphoKnee Patella Sizing Template because the markings on two arms of the instrument were mixed up. This error occurred because the triangular template was inserted upside down during the laser marking process. Only 8 units are affected by this labeling defect, which was distributed to healthcare facilities in five states. Consumers and healthcare providers should contact their facility or the manufacturer to confirm if their specific instrument is part of the affected lot.

Risk

The incorrect markings on the sizing template could lead to an inaccurate measurement of the patella during surgical procedures, potentially resulting in the selection of an incorrectly sized implant. This may cause surgical delays or complications for the patient.

What You Should Do

  1. Identify if you have the affected instrument by checking for LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00.
  2. Specifically look for Lot number C225066 and UDI-DI 04026575310203 on the device or its packaging.
  3. Stop using any instrument identified with the affected lot number immediately.
  4. Contact your healthcare provider or the manufacturer, LINK BIO CORP, at their Dover, New Jersey location for further instructions on returning the device and receiving a replacement.
  5. For additional information, you may 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

๐Ÿ“‹Other Action

Manufacturer contact for instructions

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

Affected Products

Product: LINK SymphoKnee Patella Sizing Template
Model / REF:
881-509/00
UPC Codes:
04026575310203
Lot Numbers:
C225066

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94926
Status: Active
Manufacturer: LINK BIO CORP
Sold By: authorized distributors; medical facilities
Manufactured In: United States
Units Affected: 8 units
Distributed To: Florida, Georgia, Kansas, Ohio, Wisconsin

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 ยท 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.