Clariance-SAS is recalling 511 Elegance Anterior Cervical Plates because of a quality issue involving the presence of metal burrs on the finished plates. These titanium alloy implants are used in neck surgeries to restore intervertebral height and stability. The recall affects 1-level, 2-level, and 3-level plates across several sizes and lot numbers. While no injuries have been reported to date, the presence of these sharp metal fragments on the device surface poses significant health risks once implanted.
Metal burrs on the cervical plates can cause irritation, tissue damage, or inflammation in the surrounding surgical area. There is also a risk that the burrs could detach, leading to localized reactions or complications requiring additional medical intervention.
The Elegance Anterior Cervical plate consists of titanium alloy (ASTM F136) plates with various shapes and sizes from one to five levels.
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
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