iBur 8431-009-040Recalls & reported problems
Stryker Corporation · 4.0mm Precision Round, Distal Bend · Class 2
All models of iBur (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 24, 2024Class IICompleted
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-2723-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices
- NA EMAX2PLUSSynthes GmbH · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)2,623 reports
- MIDAS REX MR8 MR8-AF02Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)952 reports
- Indigo™ 1845000Medtronic Xomed, Inc. · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)416 reports
- MIDAS REX MR8 MR8-AS07Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)232 reports
- MIDAS REX MR8 MR8-AA10Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)192 reports
- Midas Rex MR8 MR8-AF02Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)189 reports
- NA 5407-FA2-000Stryker Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)181 reports
- Indigo™ 1845000Medtronic Xomed, Inc. · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)165 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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