Nobel Biocare recalls guided drills due to potential contamination from packaging issues. Affected products may not stay 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 guided drills that could become contaminated after sterilization due to packaging defects. This poses a risk of infection during medical procedures if the devices are used without proper sterility.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices could become contaminated over time. This contamination could lead to infections during medical procedures if the devices are not properly sterilized.
Patients and medical professionals using the recalled guided drills for bone surgery procedures. Those with the specific model numbers listed in the recall are most at risk.
The affected drills have model numbers starting with (01)07332747065701(10)73499 and catalog number 37052. They are used for preparing osteotomies in bone surgery procedures.
Verify the model number and catalog number on the device to confirm if it is affected.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices could become contaminated over time.
Check the model number and catalog number on the device to confirm if it is affected. If it is, contact Nobel Biocare for further instructions.
The recall is for potential contamination, which could lead to infections during medical procedures, but not a direct risk of serious injury in normal use.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1305-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1305-2020 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.
