Skip to content

iBur 8431-012-020DRecalls & reported problems

Stryker Corporation · 2.0mm Diamond Round, Distal Bend · Class 2

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. Jul 24, 2024Completed

    Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

    Z-2724-2024 · Root cause: Under Investigation by firm · FDA record ↗

Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices

All DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices →

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