Waldemar Link GmbH & Co. KG is recalling 8 units of the MobileLink Acetabular Cup System, specifically the Shell/Insert Adapter for Shell 74-80mm. The product is incorrectly labeled with the wrong offset measurement (+12mm Offset 20 degrees Inclination). Using a component with an incorrect offset can lead to surgical complications, improper implant fit, or the need for revision surgery to correct the mechanical alignment of the hip replacement.
The incorrect offset labeling may cause a surgeon to select and implant a device that does not match the patient's anatomical requirements or the surgical plan. This could result in joint instability, leg length discrepancy, or premature wear of the hip system.
Contact healthcare provider or manufacturer
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.
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 · 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.