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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 Heads Recalled for Potential Packaging and Labeling Errors

Agency Publication Date: January 17, 2025
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Summary

Stryker Corporation is recalling approximately 1,953 units of its 3.0MM Neuro Match Head and 3.0MM Precision Neuro Match Head surgical tools used to cut bone and cement during neurosurgery. The recall was initiated because the device inside the package might not match the model information printed on the outer label. No injuries have been reported to date, but the firm is voluntarily recalling the affected lots to prevent surgical errors.

Risk

A packaging error where the label does not match the tool inside could lead a surgeon to use the wrong instrument during a delicate neurosurgical procedure. This could result in surgical delays or unintended damage to bone or surrounding tissue if the incorrect cutting head is used.

What You Should Do

  1. The recalled products include Stryker 3.0MM Neuro Match Heads (REF 5820-107-430) and 3.0MM Precision Neuro Match Heads (REF 5820-107-530) with lot numbers 22174017, 22179047, 22179027, and 22160017.
  2. Stop using the recalled surgical devices immediately and remove them from your active inventory.
  3. Contact Stryker Corporation or your authorized medical distributor to arrange for the return, replacement, or correction of any affected units in your possession.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding medical device safety.

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: stryker 3.0MM Neuro Match Head
Model / REF:
5820-107-430
Lot Numbers:
22174017
GTIN:
04546540467775

Recall #: Z-0981-2025; Quantity: 464 units

Product: stryker 3.0MM Precision Neuro Match Head
Model / REF:
5820-107-530
Lot Numbers:
22179047
22179027
22160017
GTIN:
07613154028177

Recall #: Z-0982-2025; Quantity: 1,489 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95998
Status: Active
Manufacturer: Stryker Corporation
Sold By: authorized medical distributors; hospital procurement channels
Manufactured In: United States
Units Affected: 2 products (464 units; 1489 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.