Nobel Biocare recalls abutment screw retrieval instruments due to potential packaging issues that may compromise sterilization during shelf life. Affected units include specific catalog numbers and models sold in the US.
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 instruments because the packaging might not keep them sterile for the full shelf life. This could lead to infections if the instruments are used without proper sterilization.
The packaging sealing process at the supplier may not be reliable, meaning the instruments could become contaminated over time. This contamination could lead to infections if the instruments are used without proper sterilization.
Dentists and dental clinics using the recalled instruments for abutment screw retrieval procedures are most at risk if they use the instruments without proper sterilization.
Check for catalog numbers 37503 and model 3.0/NP on the packaging. The instruments are sold in the US and were manufactured with specific packaging that may not seal properly.
Look for catalog numbers 37503 and model 3.0/NP on the packaging to identify affected units.
The packaging sealing process at the supplier may not be reliable, which could lead to contamination of the instruments over time.
The recall record does not specify a remedy or action steps for affected users.
The recall record states the instruments can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel, but the risk of contamination exists.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1322-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1322-2020 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.
