Nobel Biocare recalls specific guided drills due to potential contamination from packaging. Affected units may not remain sterile during shelf life, risking infection during medical procedures.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Nobel Biocare is recalling certain guided drills that could become contaminated during storage. This poses a risk of infection if the drills are used in medical procedures after the recall date.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices might not stay sterile throughout their shelf life. If the drills become contaminated, they could cause infections during medical procedures.
Medical professionals using the recalled drills for bone surgery procedures are most at risk. Patients receiving these drills for osteotomies could be affected if the devices are contaminated.
Check for the model number 37075 or the catalog numbers listed in the recall notice. The drills are used for preparing osteotomies for specific implants.
Identify the model number or catalog number on the drill packaging to confirm if it is affected.
The packaging sealing process at the supplier may have failed, so the sterilized devices might not stay sterile throughout their shelf life.
The recall record does not specify a remedy, so contact Nobel Biocare directly for guidance.
The recall is about potential contamination, not direct injury from use. However, contaminated devices could lead to infections during medical procedures.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1306-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1306-2020 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.
