Centinel Spine, Inc. is recalling 30 units of its Prodisc C SK Total Cervical Disc Replacement implants due to a labeling error. The 6mm extra-large implants were mistakenly labeled as 5mm, while the 5mm extra-large implants were labeled as 6mm. This mix-up could lead to a surgeon selecting and attempting to implant the wrong size disc during surgery.
Using an incorrectly sized spinal disc implant can result in surgical delays, improper fit within the spine, or the need for additional medical procedures to correct the placement of the device.
Total cervical disc replacement.
Total cervical disc replacement.
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.