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NobelReplace® 37095Recalls & reported problems

Nobel Biocare AB · Dense Bone Drill Tapered NP 3.5x16 mm Single-Patient Use · Class 1

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 14, 2019Terminated

    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.

    Z-1314-2020 · Root cause: Packaging process control · FDA record ↗

Other Accessories, implant, dental, endosseous devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.