Nobel Biocare recalls guided drills due to potential contamination from packaging issues. Affected models may not stay sterile during shelf life. Consumers should contact for details.
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 as intended, which could lead to infections if used in procedures.
The packaging sealing process at the supplier has a defect, so the sterilized devices might not stay sterile over time. This could lead to contamination if the devices are used in medical procedures without being properly sterilized.
Patients and medical professionals using the guided drills for bone procedures. Those with the specific model numbers and catalog codes are most at risk.
Check for the model number 'Drill Tapered NP 3.5x11.5 mm Single-Pat' and catalog code '37076'. The product was sold with the part number (01)07332747065671(10)73280.
Identify the model number and catalog code to confirm if your drill is affected.
The packaging sealing process at the supplier has a defect, so the sterilized devices might not stay sterile during their shelf life.
Check for the model number 'Drill Tapered NP 3.5x11.5 mm Single-Pat' and catalog code '37076'.
The recall record does not specify a remedy, so contact Nobel Biocare directly for further instructions.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1307-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1307-2020 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.
