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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

Wishbone Medical, Inc.: WishFIX Growth Control Plating System Recalled for Incorrect Implant Material

Agency Publication Date: May 10, 2024
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Summary

Wishbone Medical, Inc. is recalling 60 units of its WishFIX Growth Control Plating System, model TEFCS28-080US. These orthopedic devices were incorrectly packaged with a stainless-steel implant instead of the titanium implant specified on the packaging and part number. This manufacturing error could lead to the wrong material being surgically implanted into a patient. Consumers should contact their healthcare provider or the manufacturer to discuss any concerns regarding these devices.

Risk

If a patient receives a stainless-steel implant instead of a titanium one, it can lead to adverse biological reactions, metal sensitivities, or complications if the patient requires specific imaging like an MRI. While no injuries have been reported, the use of incorrect materials in orthopedic surgery poses a moderate risk to patient safety.

What You Should Do

  1. Identify if your device is affected by checking for WishFIX Growth Control Plating System with Model Number TEFCS28-08-US and Lot Number 28042.
  2. Verify the UDI/DI on the packaging matches code B562TEFCS2808US0.
  3. Healthcare providers and facilities should immediately stop using products from this specific lot and quarantine any remaining inventory.
  4. Contact your healthcare provider or Wishbone Medical, Inc. for further instructions regarding the return of affected devices and to determine if a refund or replacement is available.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider consultation

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

Affected Products

Product: WishFIX Growth Control Plating System Orthopedic device
Model / REF:
TEFCS28-080US
TEFCS28-08-US
Lot Numbers:
28042

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94405
Status: Active
Manufacturer: Wishbone Medical, Inc.
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 60 units
Distributed To: Florida, New Jersey, Connecticut
Agency Last Updated: May 14, 2024

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.