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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

Limacorporate S.p.A: PHYSICA HPS Tibial Liner Recalled Due to Incorrect Product Labeling

Agency Publication Date: December 9, 2023
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Summary

Limacorporate S.p.A is recalling 33 PHYSICA HPS Tibial Liner #6 H10 orthopedic implants because the products were distributed with incorrect labeling. This error could lead to the surgical implantation of an incorrect component or size, which may result in poor joint fit or the need for revision surgery. These devices were distributed in Arizona, California, Illinois, Louisiana, and New York. Consumers who have undergone knee replacement surgery involving this specific component should contact their surgeon or healthcare provider to discuss the status of their implant.

Risk

Incorrect product labeling on surgical implants can lead to the use of a device that does not match the patient's surgical requirements or the size expected by the surgeon. This poses a risk of improper joint alignment, premature device wear, or the necessity for additional corrective surgical procedures.

What You Should Do

  1. Check your medical records or contact your orthopedic surgeon to determine if a PHYSICA HPS Tibial Liner #6 H10 (REF 6539.54.610) was used in your procedure.
  2. Verify if the implanted device matches the following Lot and Sterilization numbers: 2122621 / 2200149 or 2203871 / 2200167.
  3. If you have an affected device, contact your healthcare provider immediately to discuss your clinical status and any necessary follow-up care.
  4. Contact Limacorporate S.p.A for more information regarding this recall and for instructions on how to proceed if you have unused inventory.
  5. For additional information, contact the FDA at 1-888-463-6332 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: PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Model / REF:
6539.54.610
UPC Codes:
08033390212786
Lot Numbers:
2122621 / 2200149
2203871 / 2200167
6539

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93329
Status: Active
Manufacturer: Limacorporate S.p.A
Sold By: Authorized medical distributors
Manufactured In: Italy
Units Affected: 33 devices
Distributed To: Arizona, California, Illinois, Louisiana, New York

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.