Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnioniBur08858251002452SR
Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
11 linked reportsMalfunction 11
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.29 |
| 2019-02 | 0 | 3.68 |
| 2019-03 | 0 | 4.9 |
| 2019-04 | 0 | 3.39 |
| 2019-05 | 0 | 4 |
| 2019-06 | 0 | 3.65 |
| 2019-07 | 0 | 3.23 |
| 2019-08 | 0 | 3.89 |
| 2019-09 | 0 | 2.94 |
| 2019-10 | 0 | 3 |
| 2019-11 | 0 | 3.32 |
| 2019-12 | 0 | 3.76 |
| 2020-01 | 0 | 3.19 |
| 2020-02 | 0 | 6.36 |
| 2020-03 | 0 | 5.11 |
| 2020-04 | 0 | 3.12 |
| 2020-05 | 0 | 2.9 |
| 2020-06 | 0 | 4.24 |
| 2020-07 | 0 | 3.8 |
| 2020-08 | 0 | 3.06 |
| 2020-09 | 0 | 4.6 |
| 2020-10 | 0 | 3.78 |
| 2020-11 | 0 | 4.29 |
| 2020-12 | 0 | 4.34 |
| 2021-01 | 0 | 3.3 |
| 2021-02 | 0 | 3.03 |
| 2021-03 | 0 | 3.51 |
| 2021-04 | 0 | 2.92 |
| 2021-05 | 0 | 2.73 |
| 2021-06 | 0 | 3.62 |
| 2021-07 | 0 | 3.29 |
| 2021-08 | 0 | 4.9 |
| 2021-09 | 0 | 3.59 |
| 2021-10 | 0 | 2.88 |
| 2021-11 | 0 | 3.54 |
| 2021-12 | 0 | 4.3 |
| 2022-01 | 0 | 2.93 |
| 2022-02 | 0 | 3.79 |
| 2022-03 | 0 | 3.94 |
| 2022-04 | 2 | 2.55 |
| 2022-05 | 0 | 3.36 |
| 2022-06 | 0 | 3.9 |
| 2022-07 | 3 | 3.02 |
| 2022-08 | 0 | 3.9 |
| 2022-09 | 1 | 4.04 |
| 2022-10 | 0 | 3.41 |
| 2022-11 | 0 | 3.62 |
| 2022-12 | 0 | 4.61 |
| 2023-01 | 0 | 3.21 |
| 2023-02 | 0 | 3.83 |
| 2023-03 | 0 | 3.93 |
| 2023-04 | 0 | 3.25 |
| 2023-05 | 1 | 4.68 |
| 2023-06 | 1 | 4.04 |
| 2023-07 | 0 | 2.9 |
| 2023-08 | 0 | 3.5 |
| 2023-09 | 0 | 3.58 |
| 2023-10 | 0 | 2.62 |
| 2023-11 | 0 | 4.11 |
| 2023-12 | 0 | 2.85 |
| 2024-01 | 1 | 3.18 |
| 2024-02 | 0 | 3.13 |
| 2024-03 | 0 | 3.59 |
| 2024-04 | 0 | 2.68 |
| 2024-05 | 0 | 2.7 |
| 2024-06 | 0 | 3.29 |
| 2024-07 | 0 | 2.6 |
| 2024-08 | 0 | 2.75 |
| 2024-09 | 0 | 3.49 |
| 2024-10 | 0 | 2.67 |
| 2024-11 | 0 | 2.16 |
| 2024-12 | 0 | 3.35 |
| 2025-01 | 0 | 2.56 |
| 2025-02 | 0 | 3.52 |
| 2025-03 | 0 | 2.34 |
| 2025-04 | 0 | 1.85 |
| 2025-05 | 0 | 2.19 |
| 2025-06 | 0 | 2.48 |
| 2025-07 | 1 | 2.47 |
| 2025-08 | 0 | 1.85 |
| 2025-09 | 0 | 2 |
| 2025-10 | 1 | 2.75 |
| 2025-11 | 0 | 3.08 |
| 2025-12 | 0 | 2.91 |
| 2026-01 | 0 | 2.01 |
| 2026-02 | 0 | 2.5 |
| 2026-03 | 0 | 4.3 |
| 2026-04 | 0 | 4.4 |
| 2026-05 | 0 | 4.84 |
| 2026-06 | 0 | 15.24 |
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-07-24 | Z-2728-2024 | Class II | Completed | 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.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom. | 5031 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-10-23 | 3015967359-2025-99284 | Malfunction | Available | exact di |
| 2025-07-29 | 3015967359-2025-99250 | Malfunction | Available | exact di |
| 2024-01-22 | 3015967359-2024-00232 | Malfunction | Available | exact di |
| 2023-06-23 | 3015967359-2023-01347 | Malfunction | Available | exact di |
| 2023-05-26 | 3015967359-2023-01193 | Malfunction | Available | exact di |
| 2022-09-16 | 0001811755-2022-00045 | Malfunction | Available | exact di |
| 2022-07-11 | 0001811755-2022-00027 | Malfunction | Available | exact di |
| 2022-07-11 | 0001811755-2022-00025 | Malfunction | Available | exact di |
| 2022-07-11 | 0001811755-2022-00026 | Malfunction | Available | exact di |
| 2022-04-15 | 0001811755-2022-00013 | Malfunction | Available | exact di |
| 2022-04-15 | 0001811755-2022-00014 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-18 | NAI | No action indicated | International Life Sciences | 0 |
| 2026-02-20 | VAI | Voluntary action indicated | Stryker Puerto Rico, LLC | 2 |
| 2025-12-11 | NAI | No action indicated | Stryker Manufacturing Kalamazoo | 0 |
| 2025-05-22 | NAI | No action indicated | Stryker Macroom | 0 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2025-01-30 | NAI | No action indicated | Serf | 0 |
| 2024-12-18 | VAI | Voluntary action indicated | Stryker Neurovascular | 1 |
| 2024-11-15 | VAI | Voluntary action indicated | Stryker Medical Division of Stryker Corporation | 2 |
| 2024-11-13 | NAI | No action indicated | POM Medical LLC | 0 |
| 2024-07-25 | VAI | Voluntary action indicated | Stryker Ireland, Ltd., Instruments Division | 1 |
| 2024-05-03 | NAI | No action indicated | Stryker Neurovascular, Inc. | 0 |
| 2024-04-18 | NAI | No action indicated | Physio-Control, Inc. | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2023-05-15 | VAI | Voluntary action indicated | LimFlow, Inc. | 2 |
| 2023-04-25 | NAI | No action indicated | Stryker Puerto Rico, LLC | 0 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | POM Medical LLC | 0 |
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. | — |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC | — |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
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