Nobel Biocare recalls Guided Start Drills due to potential contamination from packaging issues. Devices may not stay sterile during shelf life, risking infection. Affected units include specific model numbers.
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 Guided Start Drills that could become contaminated during storage. This poses a risk of infection if the devices are used in medical procedures after the recall date.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices might not stay sterile throughout their shelf life. This could lead to contamination if the devices are used in medical procedures.
Medical professionals using these drills for dental procedures are most at risk. Patients receiving procedures with the recalled devices could face infection.
Check for model numbers 32737 or the specific catalog number (01)07332747005295(10)73425 on the packaging. The product is used for dental procedures to prepare osteotomies.
Look for the model number 32737 or catalog number (01)07332747005295(10)73425 on the packaging.
Due to a potential packaging sealing issue that may cause sterilized devices to become contaminated during their shelf life.
Check the packaging for the model number 32737 or catalog number (01)07332747005295(10)73425. If you have the affected model, contact Nobel Biocare for further instructions.
The recall is for potential contamination risk, not direct injury. Serious injury is not mentioned in the official notice.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1302-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1302-2020 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.
