Nobel Biocare recalls abutment screw retrieval instruments due to potential contamination from packaging. Devices 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 abutment screw retrieval instruments because the packaging may not seal properly, risking contamination of sterilized devices. This could lead to infections during dental procedures if the instruments are used without proper sterility.
The packaging sealing process at the supplier may not be reliable, meaning the sterilized instruments could become contaminated over time. This contamination could lead to infections if the instruments are used in dental procedures without proper sterility checks.
Dental professionals and patients using the recalled abutment screw retrieval instruments for dental procedures. Those with the specific model number 37504 are most at risk.
Check for the model number 37504 on the instrument packaging. The product was sold with the catalog number 37504 and is used for dental procedures when abutment screws are broken.
Look for the model number 37504 on the instrument packaging to confirm if it is recalled.
The packaging sealing process at the supplier may not be reliable, meaning the sterilized instruments could become contaminated over time.
The instruments may not stay sterile during their shelf life, which could lead to infections during dental procedures if used without proper sterility checks.
Check for the model number 37504 on the instrument packaging. The product was sold with the catalog number 37504 and is used for dental procedures when abutment screws are broken.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1325-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1325-2020 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.
