Nobel Biocare recalls drill devices due to potential packaging failure that could compromise sterilization during shelf life. Affected units may not remain sterile, risking infection.
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 drill devices that could lose sterility due to packaging issues. This means the devices might not be sterile when used, increasing infection risk during dental procedures.
The packaging may not seal properly, so the sterilized devices could become contaminated over time. This could lead to infections if the devices are used without being sterile.
Dental patients and dentists who use these drills for jaw bone procedures. The risk is highest for those using the devices in procedures where sterility is critical.
Look for the drill model 'Tapered WP 5x10 mm Single-Pat' with catalog number 37085. The product was sold by Nobel Biocare USA LLC.
Verify the drill model and catalog number to confirm if it's affected.
The recall indicates a potential risk of contamination if the packaging fails, but it does not guarantee serious injury or death.
Check for the drill model 'Tapered WP 5x10 mm Single-Pat' with catalog number 37085.
The recall does not specify a remedy, so contact Nobel Biocare 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-1311-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1311-2020 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.
