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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

Orthofix Fitbone Trochanteric Nails Recalled for Potential Bending

Agency Publication Date: June 13, 2025
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Summary

Orthofix Srl is recalling 2 units of the Fitbone Trochanteric Nail (REF: 99-709245). This implantable bone lengthening device may bend at its distal tail while being inserted during surgery. If the nail bends, it must be replaced immediately during the procedure, which could prolong the surgery or cause complications. No injuries have been reported in the available data.

Risk

If the device bends during surgical insertion, the patient may experience prolonged anesthesia time and additional trauma while the surgeon replaces the damaged nail. No patient injuries or incidents have been confirmed as of this notice.

What You Should Do

  1. This recall affects the Fitbone Trochanteric Nail (L245mm, D9mm, Sterile) with model number (REF) 99-709245 and UDI 18059015373653.
  2. Check the product packaging for lot numbers B4771336 or B4771337 to determine if your inventory is affected.
  3. Stop using the recalled device immediately.
  4. Contact Orthofix Srl or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. For additional questions, call the FDA at 1-888-463-6332.

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: Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Model / REF:
99-709245
Lot Numbers:
B4771336
B4771337
UDI:
18059015373653

Recall Number: Z-1977-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96905
Status: Active
Manufacturer: Orthofix Srl
Sold By: Authorized medical distributors
Manufactured In: Italy
Units Affected: 2 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.