Nobel Biocare recalls certain implant retrieval instruments due to potential contamination from improper packaging sealing, risking infection during medical 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 specific implant retrieval instruments that may not stay sterile due to packaging issues. This could lead to infections if used in medical procedures.
The packaging sealing process at the supplier may have failed, meaning the sterilized instruments could become contaminated over time. This contamination risk increases if the instruments are used in medical procedures without proper sterility.
Medical professionals who use these instruments for implant removal are most at risk. Patients receiving procedures with these instruments could face infection.
Look for instruments labeled 'Hex & Tri-Ch NP/RP 22mm' with catalog numbers 37471 or the specific serial numbers listed in the recall notice.
Verify the product name and catalog number on the instrument to confirm if it is affected by this recall.
The recall is due to a potential issue in the packaging sealing process that could lead to contamination of sterilized medical devices.
The official recall notice does not specify a remedy or action steps for affected products.
The recall indicates a risk of contamination, not direct injury from use. However, infection is a potential consequence if the instruments are not sterile.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1316-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1316-2020 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.
