iBurRecalls & reported problems across all models

We found 15 models of iBur by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Dec 23, 2021 and Jul 22, 2026 — classified as 1 injury, 61 malfunctions.

The most frequently reported specific device problem is “Fracture” (50 reports).

10 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

iBur recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-2731-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-2730-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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-2729-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. 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-2728-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. 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-2727-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. 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-2726-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. 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-2725-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. 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 · Recall details · FDA record ↗

9. 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-2723-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. 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-2722-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported iBur problems

iBur models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• iBur 8431-013-050DC

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall19 reports
• iBur 8431-013-040DC

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall11 reports
• iBur 8431-107-030D

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall7 reports
• iBur 8431-012-040D

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall5 reports
• iBur 8431-012-030D

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall2 reports
• iBur 8431-107-530

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall1 report
• iBur 8431-013-030DC

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall0 reports
• iBur 8431-009-040

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall0 reports
• iBur 8431-009-030

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall0 reports
• iBur 8431-012-020D

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 recall0 reports
• iBur 5407-120-300

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  5 reports
• iBur 8442-107-030D

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  4 reports
• iBur 8442-107-530

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  3 reports
• iBur 8442-107-025D

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  3 reports
• iBur 8442-107-525

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  2 reports

Recent iBur adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907802 ↗
• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31, 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954435 ↗
• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954334 ↗
• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163993 ↗
• MalfunctionJan 23, 2026Fracture

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163722 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399924 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) - (B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368685 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648125 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647339 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095087 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO MEDICAL INTERVENTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095086 ↗
• MalfunctionApr 30, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A SMALL HOLE WAS OBSERVED IN THE PACKAGING WHEN IT CAME OUT OF THE BOX. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937248 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE MILLING HEAD BROKE OFF DURING A CERVICAL SPINE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THE EVENT CONTRIBUTED TO A DELAY OF UNSPECIFIED DURATION. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937241 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876061 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT DURING SURGERY, A RESIDUE WAS LEAKING FROM THE HUB. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433325 ↗

Other Stryker Corporation products

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