Nobel Biocare recalls certain implant retrieval instruments due to potential contamination from packaging. Devices may not remain sterile during shelf life, 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 because their packaging may not seal properly, potentially allowing contamination. Using these instruments could lead to infections during medical procedures if not properly sterilized.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices might not stay sterile for their entire shelf life. This could lead to contamination during medical procedures if the instruments are used without proper sterilization.
Medical professionals who use these instruments for implant removal are most at risk. Patients undergoing procedures with these instruments could face infection if the devices are not sterile.
Check for the model numbers (01)07332747083804(10)73601 or (01)07332747083804(10)73298 on the packaging. These instruments are used to remove implants with specific connections.
Look for model numbers (01)07332747083804(10)73601 or (01)07332747083804(10)73298 on the packaging.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices might not stay sterile for their entire shelf life.
Using these instruments without proper sterilization could lead to infection during medical procedures.
Check for model numbers (01)07332747083804(10)73601 or (01)07332747083804(10)73298 on the packaging.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1320-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1320-2020 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.
