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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

Medtronic Xomed, Inc.: Medtronic ENT Ultra Round Steel Cutting Bur Recalled for Past Expiration Date

Agency Publication Date: September 12, 2024
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Summary

Medtronic Xomed, Inc. is recalling one unit of the Medtronic ENT Ultra Round Steel Cutting Bur (Model Number REF 31313069) because the product was distributed after its official expiration date. Use of a medical device past its expiration date may mean the product's performance or sterility can no longer be guaranteed. Consumers or healthcare facilities who possess this specific lot should contact the manufacturer immediately for instructions on returning the item.

Risk

The product was distributed past its expiration date, which may compromise the integrity of the device or its packaging. This could potentially lead to reduced performance during surgical procedures or an increased risk of infection if the sterility of the tool is no longer maintained.

What You Should Do

  1. Identify if you have the affected surgical tool by checking the packaging for Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069.
  2. Specifically look for UDI/DI 0076300004142 and Lot Number 0219937928 on the product label.
  3. If you have this specific lot, do not use the device and set it aside to ensure it is not used in any medical procedures.
  4. Contact Medtronic Xomed, Inc. or your healthcare provider to arrange for the return of the expired unit and to discuss potential replacements or refunds.
  5. 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

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: Medtronic ENT Ultra Round Steel Cutting Bur
Model / REF:
REF 31313069
UPC Codes:
0076300004142
Lot Numbers:
0219937928

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95162
Status: Active
Manufacturer: Medtronic Xomed, Inc.
Manufactured In: United States
Units Affected: 1 unit

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.