Centinel Spine, Inc. is recalling 20 units of the Prodisc C SK total cervical disc replacement device because some packages were mislabeled. Units labeled as the 6mm product actually contained a 5mm product, which could lead to a surgeon using the wrong size during a spine procedure. Patients should contact their surgeon if they have questions about their specific implant.
The use of a 5mm disc when a 6mm disc is intended could result in improper fit or stabilization of the spine. While no injuries have been reported, this error could lead to surgical delays or the need for revision surgery if the size mismatch is not identified during the procedure.
Products were mislabeled as the 6mm product but included the 5mm product.
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.