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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

Stryker Neuro Match Head Burs Recalled for Incorrect Product Labeling

Agency Publication Date: January 17, 2025
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Summary

Stryker Corporation is recalling 491 Neuro Match Head Soft Touch burs because the device inside the packaging may not match the model number printed on the outer label. For example, a package labeled as a 3.0MM Neuro Match Head Soft Touch bur (model 5820-107-030) may actually contain a 3.0MM Prec Neuro Match Head bur (model 5820-107-530). These surgical tools are used during neurosurgery, spinal surgery, and other bone-cutting procedures. No incidents or injuries have been reported to date.

Risk

If a surgeon uses the wrong surgical bur during a procedure due to a labeling error, it could lead to unexpected surgical outcomes or delays while a replacement is found. This mismatch between the package label and the actual contents poses a risk to patients undergoing surgery.

What You Should Do

  1. This recall affects Stryker 3.0MM Neuro Match Head Soft Touch burs (model 5820-107-030) and 3.0MM Prec Neuro Match Head burs (model 5820-107-530) labeled with Lot Number 21341057 and GTIN 04546540362483.
  2. Stop using the recalled burs immediately and quarantine any remaining stock at your facility.
  3. Contact Stryker Corporation or your equipment distributor to arrange for the return, replacement, or correction of the affected products.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Neuro Match Head Burs (3.0MM)
Variants: Soft Touch, Prec
Model / REF:
5820-107-030
5820-107-530
Lot Numbers:
21341057
GTIN:
04546540362483

The label may state 5820-107-030 but the package may contain a 5820-107-530 device.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95996
Status: Active
Manufacturer: Stryker Corporation
Sold By: Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 491 devices
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.