Nobel Biocare recalls guided drills due to potential contamination from packaging. Affected models may not stay sterile during shelf life. Consumers should check product details and contact the company for remedies.
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 guided drills that could become contaminated during storage. This means the medical devices might not stay sterile, risking infection if used in procedures.
The packaging sealing process at the supplier has a problem, so the sterilized devices might not stay sterile over time. This could lead to infections if the drills are used in medical procedures without being properly sterilized.
Medical professionals using these drills for surgeries may be affected. Patients undergoing procedures with these drills face the risk of infection if the devices are not sterile.
Check for model numbers 37080, or the specific product codes (01)07332747065633(10)73433 and (01)07332747065633(10)73495. These drills are used for preparing osteotomies for implants.
Look for model numbers 37080 or the specific product codes listed in the recall notice.
The packaging sealing process at the supplier has a problem, so the sterilized devices might not stay sterile during their shelf life.
Check for model numbers 37080 or the specific product codes (01)07332747065633(10)73433 and (01)07332747065633(10)73495.
The recall notice does not specify a remedy, so contact Nobel Biocare for further instructions.
We’ve drafted a message you can send Nobel Bioc: The Guided Drills to request your refund or repair — edit it as you like.
Subject: Recall Z-1308-2020 — Nobel Bioc: The Guided Drills Nobel Bioc: The Guided Drills Hello, I own a Nobel Bioc: The Guided Drills that is covered by recall Z-1308-2020 from Nobel Bioc: The Guided Drills. 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.
