Nobel Biocare recalls N1 TiUltra TCC RP dental implants with a sharp pin that may puncture packaging and breach sterile barrier. Affected units include specific sizes and lot numbers. Consumers should contact for details.
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Nobel Biocare is recalling certain dental implants due to a sharp pin that could puncture the packaging and compromise the sterile barrier. This risk could lead to infection if the implant is not properly sterilized.
A sharp pin formed during manufacturing may puncture the blister packaging, breaching the sterile barrier of the implant. This could allow contamination if the implant is not properly sterilized after packaging.
Dental patients who have purchased the specific Nobel Biocare N1 TiUltra TCC RP implants with the listed sizes and lot numbers are affected. Patients using these implants for dental restoration are most at risk.
Check for the product names: Nobel Biocare N1 TiUltra TCC RP 4.0x9mm, 4.0x11mm, or 4.0x13mm. Look for lot numbers 12253672, 12253673, 12253448, 12254209, or 12253620, 12254213.
Identify the specific implant size and lot numbers listed in the recall notice to confirm if your product is affected.
Nobel Biocare N1 TiUltra TCC RP implants with sizes 4.0x9mm, 4.0x11mm, or 4.0x13mm and specific lot numbers (12253672, 12253673, 12253448, 12254209, 12253620, 12254213).
Due to a manufacturing issue where a sharp pin may puncture the blister packaging and breach the sterile barrier of the finished product.
The recall notice does not specify a remedy; contact Nobel Biocare directly for further instructions.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1101-2025 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1101-2025 from Nobel Biocare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
