Nobel Biocare recalls Abutment Screw Retrieval Kit due to potential contamination of sterilized medical devices from packaging issues. Affected units may not remain sterile during shelf life.
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 Kits because the packaging may not seal properly, risking that sterilized medical devices become contaminated over time. This could lead to infections if used in medical procedures.
The packaging sealing process at the supplier may fail, causing sterilized devices to become contaminated. If the devices are used in medical procedures without being sterile, infections could occur.
Medical professionals using the kit for dental procedures are most at risk. Patients receiving dental treatments with the recalled kit could face infection risks.
The kit has catalog number 37481. It was sold with specific model numbers (01)07332747083866(10)818727 and (01)07332747083866(10)818683.
Look for catalog number 37481 on the kit packaging to confirm if it is affected.
The recall states the kit may not remain sterile during shelf life, so it is not safe for use without proper sterilization checks.
Check for catalog number 37481 and model numbers (01)07332747083866(10)818727 or (01)07332747083866(10)818683.
The recall does not specify a remedy, so contact Nobel Biocare directly for guidance.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1324-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1324-2020 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.
