Nobel Biocare recalls Dense Bone Drills 6.0 6x16 mm single-patented models due to potential contamination from packaging. These devices may not stay sterile during shelf life, risking infection after surgery.
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 is recalling Dense Bone Drills 6.0 6x16 mm single-patented models because the packaging may not keep them sterile. Using these drills could lead to infections after surgery if the devices are not properly sterilized.
The packaging sealing process at the supplier may not be reliable, so the sterilized devices could become contaminated over time. This contamination risk could lead to infections during or after surgery if the devices are not properly sterilized.
Surgical patients and medical professionals who use these bone drills for procedures. Those with the specific model numbers and catalog codes listed are most at risk.
Check for the model number 6.0 6x16 mm Single-Patented on the product label. The catalog number 37049 is also associated with this recall.
Look for the model number 6.0 6x16 mm Single-Patented and catalog number 37049 on the device.
The packaging sealing process at the supplier may not be reliable, so the sterilized devices could become contaminated over time.
Using these drills could lead to infections after surgery if the devices are not properly sterilized.
Check for the model number 6.0 6x16 mm Single-Patented and catalog number 37049 on the device.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1304-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1304-2020 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.
