Nobel Biocare recalls drill products 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 dental drills that could become contaminated during storage. Using these drills without proper sterilization might lead to infections during dental surgery.
The packaging sealing issue means sterilized dental drills might not stay sterile over time. If the drills become contaminated, they could cause infections during dental procedures if used without proper re-sterilization.
Dental professionals and patients using Nobel Biocare's Drill Tapered WP 5x11.5 mm Single-Pat dental drills. Those with the specific catalog number 37086 are most at risk.
Check for the catalog number 37086 on the drill packaging. The product is intended for use in upper and lower jaw bone preparation during dental implant procedures.
Look for the catalog number 37086 on the drill packaging to confirm if it's affected.
Due to a packaging sealing problem that might cause sterilized devices to become contaminated over time.
The recall does not specify that using the drills is unsafe; however, they may not stay sterile, so proper re-sterilization is needed if used.
The recall record does not provide a specific remedy or action for affected units.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1312-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1312-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
