Nobel Biocare recalls drill products due to potential packaging issues that could compromise sterilization during shelf life. Affected items may not remain sterile, 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 Bioc: 6.0 6x8 mm Single-Pat drills are recalled because their packaging might not keep them sterile for the full shelf life. This could lead to infections if used in dental procedures without proper sterilization.
The packaging sealing process at the supplier may not be reliable, so the sterilized devices might not stay sterile throughout their shelf life. This could lead to infections during dental procedures if the drills are used without proper sterilization.
Dental professionals using these drills for jaw bone procedures are most at risk. Patients receiving dental implants using these drills could face infection if the devices aren't properly sterilized.
Check for the model 'Drill Tapered 6.0 6x8 mm Single-Pat' with catalog number 37089. These drills are used in dental procedures for jaw bone preparation before implant placement.
Inspect the packaging for signs of poor sealing, though the recall does not specify visual indicators.
The packaging sealing process at the supplier may not be reliable, so the sterilized devices might not stay sterile throughout their shelf life.
Look for the model 'Drill Tapered 6.0 6x8 mm Single-Pat' with catalog number 37089, used in dental procedures for jaw bone preparation.
The recall does not specify a remedy, so contact Nobel Biocare for guidance on next steps.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1313-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1313-2020 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.
