Centinel Spine, Inc. has recalled 18 units of the Prodisc C SK Total Cervical Disc replacement system due to the discovery of a blue discoloration on the device's inlay. This discoloration is considered a foreign contaminant that was not part of the validated manufacturing process and could pose health risks to patients. These medical devices were distributed nationwide in the United States and include model number PDSM5.
The presence of an unknown foreign contaminant on a surgical implant may lead to an adverse tissue reaction, inflammation, or infection once the device is placed inside the body.
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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.
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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
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