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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

Novosource, LLC: NovoHip Biolox Ball Head Recalled Due to Mislabeled Packaging

Agency Publication Date: November 18, 2024
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Summary

Novosource, LLC has recalled one unit of the NovoHip Biolox Ball Head 32mmL, a component of the NovoHip Total Hip System. This specific unit was packaged in a box labeled as a 32mm long head but actually contained a 28mm long head. If this incorrectly sized component is used during a hip replacement surgery, it could lead to the joint becoming unstable or failing to function correctly. Consumers should contact their surgeon or healthcare provider if they have concerns about a recent hip replacement involving this system.

Risk

The mismatch between the label and the actual device size may lead a surgeon to implant a 28mm head when a 32mm head was intended. This incorrect sizing can cause joint instability, potentially requiring additional surgery to correct the alignment and secure the hip joint.

What You Should Do

  1. Identify if you or your surgical facility has the affected NovoHip Biolox Ball Head by checking for Ref: 1345-2803 and UDI-DI 00811382037849.
  2. Check the packaging for Lot Number CER0023 to see if it matches the recalled unit.
  3. Verify the physical marking on the device itself; the box may say '32 long' while the device is actually marked as '28 long'.
  4. If you are a healthcare provider in possession of this unit, do not use it for surgery and set it aside immediately.
  5. Contact Novosource, LLC at their Morgantown, West Virginia office or via the contact information provided during the initial e-mail notification to arrange for the return or replacement of the mislabeled unit.
  6. Patients who have recently undergone hip replacement surgery using the NovoHip Total Hip System and are experiencing unusual joint instability should contact their orthopedic surgeon or healthcare provider immediately.
  7. For more information or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: NovoHip Biolox Ball Head 32mmL
Model / REF:
Ref: 1345-2803
UDI-DI 00811382037849
Lot Numbers:
CER0023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95598
Status: Active
Manufacturer: Novosource, LLC
Sold By: Specialty medical distributors
Manufactured In: United States
Units Affected: 1 unit
Distributed To: Florida, West Virginia

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.