Straumann USA LLC has recalled 507 units of GM Helix Acqua Implants because the packaging may contain an implant of the wrong size. Specifically, packages labeled as 11.5 mm implants might actually contain 13 mm implants. This labeling error was initiated voluntarily by the firm to prevent the potential use of incorrectly sized medical devices during surgical procedures.
The use of an incorrectly sized dental implant during surgery can lead to unexpected tissue damage, improper fitting in the jawbone, or surgical delays while a correct replacement is found. No injuries or incidents have been reported to date.
300 units affected (125 in the US, 175 outside the US)
207 units affected (54 in the US, 153 outside the US)
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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