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 may not stay sterile during their shelf life due to a packaging issue. This could lead to infections if the devices are used without proper sterilization.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices could become contaminated over time. This contamination risk exists if the devices are used without proper sterilization.
Patients using these guided drills for dental procedures are at risk if the devices become contaminated. Medical professionals who use the drills for osteotomies may also be affected.
Check for the model number 37045 or the catalog number (01)07332747065756(10)73466 on the packaging. The product is used for preparing osteotomies in dental procedures.
Look for the model number 37045 or the catalog number (01)07332747065756(10)73466 on the packaging.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices could become contaminated over time.
Check for the model number 37045 or the catalog number (01)07332747065756(10)73466 on the packaging.
The recall record does not specify a remedy, so contact Nobel Biocare directly for guidance.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1303-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1303-2020 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.
