Waldemar Link GmbH & Co. KG is recalling approximately 8,017 units of its Endo Model M and SL Tibial Component Modular Knee Prosthesis Systems because the blind screws used in these modular components cannot be loosened during an operation. This defect forces surgeons to unexpectedly change their procedure mid-surgery, such as switching to a cementing technique, which can cause significant delays in the operating room. The recall affects units manufactured since June 1, 2022, and distributed both nationwide and internationally.
The inability to loosen the screws during surgery can result in the prolongation of the surgical procedure and an unplanned change in the surgical technique, potentially increasing the risk of infection or anesthetic complications for the patient.
Contact healthcare provider or manufacturer for instructions.
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.