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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

TMJ Solutions Inc: TMJ Unilateral Implant Recalled for Incorrect Components

Agency Publication Date: September 26, 2024
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Summary

TMJ Solutions Inc has recalled one Stryker TMJ Unilateral Implant because it was found to contain incorrect components. This specific patient-fitted temporomandibular (TMJ) prosthesis was intended for a single patient but may not function as intended due to the parts mismatch. The affected unit consists of an anatomical bone model, a right glenoid fossa component, and a right mandibular component.

Risk

The use of incorrect components in a patient-fitted jaw implant can lead to surgical delays, improper fit, or mechanical failure of the prosthesis, potentially requiring additional medical intervention or revision surgery.

What You Should Do

  1. Identify if you are the affected patient or healthcare provider by checking the packaging for Order # 101432374 and Lot # 2403081022.
  2. Verify the device details against the following UDI numbers: (01)07613327627800 or (01)07613327625551.
  3. Contact your healthcare provider or surgeon immediately to discuss the status of the implant and any necessary medical follow-up.
  4. Contact the manufacturer, TMJ Solutions Inc, at their Ventura, California location for further instructions regarding the return or replacement of the device.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer or Healthcare Consultation

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

Affected Products

Product: Stryker TMJ Unilateral Implant (consisting of Anatomical Bone Model, Glenoid Fossa Component Right, Mandibular Component Right)
Model / REF:
GHG010
CHG010AM
CHG010RF
CHG010RM
UPC Codes:
07613327627800
07613327625551
Lot Numbers:
2403081022
Order # 101432374

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95139
Status: Active
Manufacturer: TMJ Solutions Inc
Sold By: TMJ Solutions Inc
Manufactured In: United States
Units Affected: 1
Distributed To: Minnesota

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.