Straumann USA LLC is recalling 20 units of custom dental abutments because a manufacturing error led to a material mix-up. During production, a specific titanium alloy (TAN-material) was incorrectly used instead of the intended Grade 4 Titanium. This affected specific Custom Abutment Ti and Custom Abutment AS Ti models distributed worldwide, including 10 U.S. states and Canada.
The use of an incorrect raw material in the dental abutment could compromise the mechanical integrity or biocompatibility of the implant. This may lead to device failure, potential injury to the patient's jaw or gums, or the need for corrective dental procedures.
Manufactured using TAN Bar material instead of Titanium Bar Ti Gr4 D on Mill-from-Bar Machine 396-06.
Manufactured using TAN Bar material instead of Titanium Bar Ti Gr4 D on Mill-from-Bar Machine 396-06.
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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