Nobel Biocare recalls guided drills that may not stay sterile during shelf life due to packaging issues. Affected models include specific drill sizes for dental procedures. 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 Bioc:care is recalling guided dental drills that could become contaminated if the packaging doesn't seal properly. This means the sterilized devices might not stay sterile during their shelf life, posing a risk of infection during dental 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 contamination if the devices are used for dental procedures without being properly sterilized.
Dental professionals and patients using the specific guided drills for dental procedures. Those with the affected model numbers are most at risk.
Check for model numbers 37081, or the specific drill sizes listed in the product description. The affected drills are used for preparing osteotomies for dental implants.
Look for model numbers 37081 or the specific drill sizes listed in the product description to confirm if your device is affected.
The packaging sealing process at the supplier has a problem, so the sterilized devices might not stay sterile during their shelf life.
The official notice does not specify a remedy for this recall.
Yes, check for model numbers 37081 or the specific drill sizes listed in the product description.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1309-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1309-2020 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.
