Nobel Biocare recalls certain implant retrieval instruments due to potential packaging failure that could compromise sterility during shelf life. Affected products may not remain sterile, 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 might not stay sterile long enough. This could lead to infections during medical procedures if the instruments are used without proper sterilization.
The packaging sealing process has a defect that might allow contamination. If the instruments are not sterile when used, medical procedures could become infected, leading to complications for patients.
Medical professionals who use these instruments for implant removal are most at risk. Patients receiving procedures with these instruments could face infection if the instruments are not properly sterilized.
Check for the model number 6.0 22 mm on the instrument. The product was sold with catalog number 37476 and may have been purchased around the time of the recall announcement.
Inspect the packaging for signs of damage or improper sealing before use.
The recall is about potential contamination risk, not direct injury from the instruments themselves.
Look for the model number 6.0 22 mm and catalog number 37476 on the instrument.
The recall does not require immediate discontinuation; checking packaging integrity is sufficient.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1321-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1321-2020 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.
