Nobel Biocare recalls Dense Bone Drills WP 5x13 mm Single-Pat due to potential contamination from packaging. Affected devices 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 used in dental procedures because the packaging might not keep them sterile. This could lead to infections if the drills are used without proper sterilization.
The packaging sealing process at the supplier may have failed, meaning the drills might not stay sterile during their shelf life. This could lead to contamination if the devices are used without proper sterilization during dental procedures.
Dental professionals who use these drills for jaw bone procedures are most at risk. Patients using the recalled drills could face infection if the devices aren't properly sterilized.
Check for the product name 'Dense Bone Drill WP 5x13 mm Single-Pat' or catalog number 37098. These drills are used for jaw bone procedures to prepare for dental implants.
Inspect the packaging for signs of improper sealing, though the recall does not specify how to identify affected units.
The packaging sealing process at the supplier may have failed, meaning the drills might not stay sterile during their shelf life.
Look for the product name 'Dense Bone Drill WP 5x13 mm Single-Pat' or catalog number 37098.
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-1315-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1315-2020 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.
