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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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High RiskFDA Device
Medical Devices/Surgical Equipment

Stryker Corporation: 1.2mm Cross Cut Fissure Surgical Burrs Recalled for Endotoxin Contamination

Agency Publication Date: October 11, 2024
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Summary

Stryker Corporation is recalling 307 units of its 1.2mm Cross Cut Fissure surgical burrs because they may contain elevated endotoxin levels. These devices are used in a variety of delicate surgeries, including neurosurgical, spinal, and dental procedures, for cutting or shaping bone and teeth. The presence of high endotoxin levels can trigger serious inflammatory responses or fever in patients following surgery.

Risk

Exposure to high levels of endotoxins can cause systemic inflammation and fever. If these contaminated surgical tools come into contact with cerebrospinal fluid during brain or spine procedures, there is a specific risk of the patient developing meningitis.

What You Should Do

  1. Identify if you have the affected surgical tool by checking for the 1.2mm Cross Cut Fissure with Catalog Number 5820-066-012 and GTIN 04546540362346.
  2. Verify the specific batch by looking for Lot Number 22329017 on the product packaging.
  3. Immediately stop using any surgical burrs identified with this specific lot number and quarantine the affected inventory to prevent further use.
  4. Contact your healthcare provider or Stryker Corporation directly at 269-323-7700 or visit their website at www.stryker.com for instructions on returning the product and obtaining a replacement.
  5. If you are a patient who has recently undergone a neurosurgical, spinal, or dental procedure and are experiencing unexplained fever or inflammation, contact your doctor immediately.
  6. For additional questions or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

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

Affected Products

Product: 1.2mm Cross Cut Fissure Surgical Burr
Model / REF:
5820-066-012
UPC Codes:
04546540362346
Lot Numbers:
22329017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95342
Status: Active
Manufacturer: Stryker Corporation
Sold By: authorized medical distributors; hospital systems
Manufactured In: United States
Units Affected: 307 units
Distributed To: Nationwide

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.