Encore Medical, LP (Enovis) is recalling 58 EMPOWR 3D Knee Tibial Insert - E-PLUS implants because they were shipped with incorrect labeling. The labels may list the wrong size or side (left versus right), which could lead to the wrong component being selected for a patient's total knee replacement surgery. These implants are used in surgeries to restore mobility and reduce pain in patients who are candidates for knee arthroplasty.
If an incorrectly labeled implant is used during surgery, a patient could receive a component that does not fit correctly or is for the wrong side of the body. This could result in surgical delays, poor joint function, or the need for a follow-up revision surgery.
Quantity: 18 implants
Quantity: 40 implants
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.