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 because their packaging may not seal properly, which could lead to contaminated devices. This poses a risk of infection during medical procedures if the instruments are used without proper sterilization.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices might not stay sterile over time. If the instruments become contaminated, they could cause infections during medical procedures.
Medical professionals who use these instruments for implant removal are most at risk. Patients receiving procedures with these instruments could face infection if the devices are not sterile.
Check for the model numbers (01)07332747083798(10)73614 and (01)07332747083798(10)73256 on the packaging. These instruments are used to remove implants with specific connections.
Look for the model numbers (01)07332747083798(10)73614 and (01)07332747083798(10)73256 on the packaging to identify affected instruments.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices might not stay sterile over time, risking infection during medical procedures.
Check the packaging for the model numbers (01)07332747083798(10)73614 and (01)07332747083798(10)73256 to identify if it's affected. No specific action is required beyond checking.
The recall is about potential contamination from improper packaging, not direct injury from use. However, using contaminated instruments could lead to infection.
We’ve drafted a message you can send Nobel Bioc: The brand name from the manufacturer title is to request your refund or repair — edit it as you like.
Subject: Recall Z-1319-2020 — Nobel Bioc: The brand name from the manufacturer title is Nobel Bioc: The brand name from the manuf Hello, I own a Nobel Bioc: The brand name from the manufacturer title is that is covered by recall Z-1319-2020 from Nobel Bioc: The brand name from the manufacturer title is. 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.
