Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

iBur

Model 8431-013-050DC · STRYKER CORPORATION · DI 07613327501186

HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2024-07-24Z-2729-2024Class IICompletedPotential 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.code info di

Adverse-event reports — MAUDE (22)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 18 · Injury: 4

4811152019-01: 0 reports for this device; peer average 2.29/device2019-02: 0 reports for this device; peer average 3.68/device2019-03: 0 reports for this device; peer average 4.9/device2019-04: 0 reports for this device; peer average 3.39/device2019-05: 0 reports for this device; peer average 4/device2019-06: 0 reports for this device; peer average 3.65/device2019-07: 0 reports for this device; peer average 3.23/device2019-08: 0 reports for this device; peer average 3.89/device2019-09: 0 reports for this device; peer average 2.94/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 3.32/device2019-12: 0 reports for this device; peer average 3.76/device2020-01: 0 reports for this device; peer average 3.19/device2020-02: 0 reports for this device; peer average 6.36/device2020-03: 0 reports for this device; peer average 5.11/device2020-04: 0 reports for this device; peer average 3.12/device2020-05: 0 reports for this device; peer average 2.9/device2020-06: 0 reports for this device; peer average 4.24/device2020-07: 0 reports for this device; peer average 3.8/device2020-08: 0 reports for this device; peer average 3.06/device2020-09: 0 reports for this device; peer average 4.6/device2020-10: 0 reports for this device; peer average 3.78/device2020-11: 0 reports for this device; peer average 4.29/device2020-12: 0 reports for this device; peer average 4.34/device2021-01: 0 reports for this device; peer average 3.3/device2021-02: 0 reports for this device; peer average 3.03/device2021-03: 0 reports for this device; peer average 3.51/device2021-04: 0 reports for this device; peer average 2.92/device2021-05: 0 reports for this device; peer average 2.73/device2021-06: 0 reports for this device; peer average 3.62/device2021-07: 0 reports for this device; peer average 3.29/device2021-08: 0 reports for this device; peer average 4.9/device2021-09: 0 reports for this device; peer average 3.59/device2021-10: 0 reports for this device; peer average 2.88/device2021-11: 0 reports for this device; peer average 3.54/device2021-12: 0 reports for this device; peer average 4.3/device2022-01: 0 reports for this device; peer average 2.93/device2022-02: 0 reports for this device; peer average 3.79/device2022-03: 0 reports for this device; peer average 3.94/device2022-04: 0 reports for this device; peer average 2.55/device2022-05: 0 reports for this device; peer average 3.36/device2022-06: 0 reports for this device; peer average 3.9/device2022-07: 0 reports for this device; peer average 3.02/device2022-08: 0 reports for this device; peer average 3.9/device2022-09: 3 reports for this device; peer average 4.04/device2022-10: 0 reports for this device; peer average 3.41/device2022-11: 0 reports for this device; peer average 3.62/device2022-12: 0 reports for this device; peer average 4.61/device2023-01: 0 reports for this device; peer average 3.21/device2023-02: 0 reports for this device; peer average 3.83/device2023-03: 2 reports for this device; peer average 3.93/device2023-04: 1 reports for this device; peer average 3.25/device2023-05: 2 reports for this device; peer average 4.68/device2023-06: 2 reports for this device; peer average 4.04/device2023-07: 4 reports for this device; peer average 2.9/device2023-08: 0 reports for this device; peer average 3.5/device2023-09: 1 reports for this device; peer average 3.58/device2023-10: 2 reports for this device; peer average 2.62/device2023-11: 0 reports for this device; peer average 4.11/device2023-12: 0 reports for this device; peer average 2.85/device2024-01: 1 reports for this device; peer average 3.18/device2024-02: 1 reports for this device; peer average 3.13/device2024-03: 0 reports for this device; peer average 3.59/device2024-04: 0 reports for this device; peer average 2.68/device2024-05: 1 reports for this device; peer average 2.7/device2024-06: 0 reports for this device; peer average 3.29/device2024-07: 0 reports for this device; peer average 2.6/device2024-08: 1 reports for this device; peer average 2.75/device2024-09: 0 reports for this device; peer average 3.49/device2024-10: 0 reports for this device; peer average 2.67/device2024-11: 0 reports for this device; peer average 2.16/device2024-12: 0 reports for this device; peer average 3.35/device2025-01: 0 reports for this device; peer average 2.56/device2025-02: 0 reports for this device; peer average 3.52/device2025-03: 0 reports for this device; peer average 2.34/device2025-04: 0 reports for this device; peer average 1.85/device2025-05: 0 reports for this device; peer average 2.19/device2025-06: 0 reports for this device; peer average 2.48/device2025-07: 0 reports for this device; peer average 2.47/device2025-08: 0 reports for this device; peer average 1.85/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2.75/device2025-11: 0 reports for this device; peer average 3.08/device2025-12: 0 reports for this device; peer average 2.91/device2026-01: 1 reports for this device; peer average 2.01/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 4.3/device2026-04: 0 reports for this device; peer average 4.4/device2026-05: 0 reports for this device; peer average 4.84/device2026-06: 0 reports for this device; peer average 15.24/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.29
2019-0203.68
2019-0304.9
2019-0403.39
2019-0504
2019-0603.65
2019-0703.23
2019-0803.89
2019-0902.94
2019-1003
2019-1103.32
2019-1203.76
2020-0103.19
2020-0206.36
2020-0305.11
2020-0403.12
2020-0502.9
2020-0604.24
2020-0703.8
2020-0803.06
2020-0904.6
2020-1003.78
2020-1104.29
2020-1204.34
2021-0103.3
2021-0203.03
2021-0303.51
2021-0402.92
2021-0502.73
2021-0603.62
2021-0703.29
2021-0804.9
2021-0903.59
2021-1002.88
2021-1103.54
2021-1204.3
2022-0102.93
2022-0203.79
2022-0303.94
2022-0402.55
2022-0503.36
2022-0603.9
2022-0703.02
2022-0803.9
2022-0934.04
2022-1003.41
2022-1103.62
2022-1204.61
2023-0103.21
2023-0203.83
2023-0323.93
2023-0413.25
2023-0524.68
2023-0624.04
2023-0742.9
2023-0803.5
2023-0913.58
2023-1022.62
2023-1104.11
2023-1202.85
2024-0113.18
2024-0213.13
2024-0303.59
2024-0402.68
2024-0512.7
2024-0603.29
2024-0702.6
2024-0812.75
2024-0903.49
2024-1002.67
2024-1102.16
2024-1203.35
2025-0102.56
2025-0203.52
2025-0302.34
2025-0401.85
2025-0502.19
2025-0602.48
2025-0702.47
2025-0801.85
2025-0902
2025-1002.75
2025-1103.08
2025-1202.91
2026-0112.01
2026-0202.5
2026-0304.3
2026-0404.4
2026-0504.84
2026-06015.24
This device (reports/month)Average device in HBE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations