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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/Implants & Prosthetics

Stryker GAMMA4 Right Long Nail Recalled for Incorrect Left-Side Geometry

Agency Publication Date: June 6, 2025
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Summary

Stryker GmbH has recalled one lot of the Long Nail, RIGHT Gamma4 10x320mm x 125, which is a component of the Gamma4 orthopedic surgical system. An investigation confirmed that this specific batch of nails was manufactured with the geometry of a left-side nail instead of the intended right-side geometry. Using a nail with the incorrect orientation during surgery could lead to improper fit or medical complications.

Risk

The nail features the incorrect curvature for its intended right-sided application, which may cause it to fail to fit correctly or potentially cause bone misalignment during implantation. If used, this could lead to surgical delays or the need for additional revision surgeries to correct the orientation error.

What You Should Do

  1. The recalled product is the Long Nail, RIGHT Gamma4 10x320mm x 125 (Catalog Number 84250320S, GTIN 07613327479515) with Lot Number K1BC9B7.
  2. Stop using the recalled product immediately.
  3. Contact Stryker GmbH or your medical device distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions 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: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System
Model / REF:
84250320S
Lot Numbers:
K1BC9B7
GTIN:
07613327479515

Recall Number: Z-1914-2025. This right-side nail was incorrectly manufactured with left-side geometry.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96927
Status: Active
Manufacturer: Stryker GmbH
Sold By: Hospital networks; Surgical centers; Medical device distributors
Manufactured In: Switzerland
Distributed To: Alabama, Florida, New Jersey, Oregon

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.