Exactech, Inc. has issued a voluntary recall for approximately 72,876 Equinoxe Reverse Shoulder Humeral Liners used in shoulder replacement surgeries. These polyethylene liners were found to have dimensions that fall outside the required specifications listed in the product labeling. This manufacturing issue affects several model sizes, including 38mm and 42mm versions manufactured in the United States.
The incorrect sizing of the humeral liner's articular surface can lead to improper fit or joint instability within the shoulder implant. This defect may cause premature wear of the device, restricted range of motion, or the need for revision surgery to correct the alignment of the shoulder joint.
Quantity: 61,334 UNITS
Quantity: 11,542 units
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 ยท 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.