Nobel Biocare has voluntarily recalled 1,558 units (including 90 units in the U.S.) of N1 TiUltra TCC dental implants due to a manufacturing issue where a sharp pin may puncture the blister packaging. These implants are used in the jaw to support dental prostheses like crowns or bridges. A puncture in the packaging compromises the sterile barrier of the product before it is used in surgery. To date, no injuries or incidents have been reported.
The sharp pin can breach the sterile packaging, potentially contaminating the implant. Using a non-sterile implant increases the risk of surgical site infections and complications for the patient.
Intended for use as an endosseous dental implant in the maxilla or mandible.
Intended for use as an endosseous dental implant in the maxilla or mandible.
Intended for use as an endosseous dental implant in the maxilla or mandible.
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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