Nobel Biocare recalls certain implant retrieval instruments due to packaging sealing issues that may compromise sterility during shelf life. Affected products include CC 3.0 31 mm models sold with catalog number 37473.
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 implant retrieval instruments that may not stay sterile due to packaging defects. This could lead to infections if the instruments are used without proper sterilization.
The packaging sealing process at the supplier has a defect that could allow contamination. If the instruments are not properly sterilized before use, they might cause infections during medical procedures.
Medical professionals who use these instruments for implant removal are most at risk. Patients who have received implants with damaged connections may also be affected.
Check for the model CC 3.0 31 mm with catalog number 37473. These instruments were sold with the part number (01)07332747083781(10)73306.
Inspect the packaging for signs of improper sealing before use.
Yes, if the instruments are not properly sterilized due to packaging defects.
The official recall notice does not specify a remedy or action steps for affected users.
Yes, the CC 3.0 31 mm models with catalog number 37473 are affected.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1318-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1318-2020 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.
