Nobel Biocare recalls guided drills due to potential contamination from packaging. Affected units may not stay sterile during shelf life. Consumers should contact for details.
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:care recalls guided drills that could become contaminated during storage. This means the medical devices might not stay sterile as long as labeled, risking infection during surgery.
The packaging sealing issue means sterilized devices might not stay sterile over time. This could lead to infections if the drills are used in dental procedures without proper sterility.
Patients and surgeons using the guided drills for dental procedures. Those with the specific drill model and catalog number 37082 are most at risk.
Check for the model name 'Drill Tapered RP 4.3x13 mm Single-Pat' and catalog number 37082. The product is used for dental osteotomies.
Reach out to Nobel Biocare Usa Llc for specific instructions on handling the recalled product.
Due to a packaging sealing problem that might cause sterilized devices to become contaminated over time.
The drills might not stay sterile during their shelf life, increasing infection risk during dental procedures.
Look for the model name 'Drill Tapered RP 4.3x13 mm Single-Pat' and catalog number 37082.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1310-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1310-2020 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.
