Nobel Biocare recalls N1 TiUltra TCC NP 3.5x13mm dental implants due to a burr that may cause aspiration during surgery. Affected units have specific lot numbers and UDI codes.
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Nobel Biocare is recalling a specific dental implant model because it has a burr that could cause a patient to aspirate during surgery. This is a serious risk that requires immediate attention from users.
The implant contains a burr that can cause tissue damage or aspiration (inhalation of foreign material) during surgical procedures. This poses a direct risk to patient safety during dental implant surgery.
Dental surgeons and patients using the Nobel Biocare N1 TiUltra TCC NP 3.5x13mm implant. Those with the specific lot numbers or UDI codes listed are most at risk.
Check for the product name 'Nobel Biocare N1 TiUltra TCC NP 3.5x13mm' with lot numbers 12167337, 12167830, or 12168184. UDI codes include specific sequences like (01)07332747161717(10)12167337(11)210119(17)251218.
Immediately stop using the recalled dental implant if you have the specific lot numbers or UDI codes listed in the recall notice.
The recalled model is Nobel Biocare N1 TiUltra TCC NP 3.5x13mm.
Check for lot numbers 12167337, 12167830, or 12168184, or UDI codes starting with (01)07332747161717(10) followed by the lot number.
Immediately stop using it and contact Nobel Biocare 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-1565-2022 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1565-2022 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.
