Conformis Inc. has recalled 16 units of its restor3d Cordera Hip System Acetabular Liners. The affected product, identified as Model HDL-060-C22L-000101 from Lot 1788258, was incorrectly labeled as containing a standard liner when it actually contained a hooded liner. Consumers and surgical centers should stop using the recalled device and contact the manufacturer or their distributor to arrange for a return, replacement, or correction.
The incorrect labeling could lead a surgeon to unknowingly implant a hooded liner when a standard liner was intended for the patient. There have been no reported incidents or injuries related to this labeling error.
The product from Lot 1788258 contained a hooded liner but was labeled to have a standard liner (Model HDL-060-C22S-000101 was also referenced in description of error).
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.