Nobel Biocare recalls Dense Bone Drills NP 3.5x16 mm due to potential contamination from packaging. Affected units may not stay sterile during shelf life, risking infection during dental 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 dense bone drills that could become contaminated during storage. If used in dental procedures, this might lead to infections since the devices may not stay sterile after packaging.
The packaging sealing issue means sterilized devices might not stay sterile over time. This could lead to infections during dental surgeries if the drills are used without proper sterility.
Dental professionals who use these drills for jaw bone procedures are most at risk. Patients receiving dental implants using recalled drills could be exposed to infection.
Check for the model 'Dense Bone Drill NP 3.5x16 mm Single-Pat' with catalog number 37095. The product is used for jaw bone preparation before dental implants.
Look for the model 'Dense Bone Drill NP 3.5x16 mm Single-Pat' and catalog number 37095 on the device packaging.
The packaging sealing process at the supplier may cause sterilized devices to lose sterility over time, risking infections during dental procedures.
Check for the model 'Dense Bone Drill NP 3.5x16 mm Single-Pat' with catalog number 37095 on the device packaging.
The recall 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-1314-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1314-2020 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.
