Waldemar Link GmbH & Co. KG is recalling approximately 63 units of Prosthesis Head B and Plastic Trial Heads. These surgical components are being recalled due to inconsistent size terminology and color coding used on the labeling. The affected products include 46 units of the Prosthesis Head B (28 mm) and 17 units of the Plastic Trial Head Brown.
Mismatched size information or color coding on surgical components could lead to a surgeon selecting the incorrect implant size during surgery. This can cause surgical delays or an improper fit of the prosthesis, which may lead to patient complications or the need for additional corrective surgeries.
46 units distributed.
17 units distributed.
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.