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Unnamed device

Model 5450400000 · STRYKER CORPORATION · DI 07613252468356

ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (772)

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: 772

51116212019-01: 9 reports for this device; peer average 4.2/device2019-02: 7 reports for this device; peer average 3.58/device2019-03: 21 reports for this device; peer average 6.27/device2019-04: 10 reports for this device; peer average 5.47/device2019-05: 7 reports for this device; peer average 3.92/device2019-06: 6 reports for this device; peer average 4.13/device2019-07: 14 reports for this device; peer average 4.17/device2019-08: 7 reports for this device; peer average 5.32/device2019-09: 15 reports for this device; peer average 4.17/device2019-10: 7 reports for this device; peer average 4.24/device2019-11: 9 reports for this device; peer average 5.24/device2019-12: 21 reports for this device; peer average 5.06/device2020-01: 8 reports for this device; peer average 4.4/device2020-02: 8 reports for this device; peer average 3.92/device2020-03: 10 reports for this device; peer average 4.79/device2020-04: 2 reports for this device; peer average 4.51/device2020-05: 0 reports for this device; peer average 2.98/device2020-06: 7 reports for this device; peer average 5.68/device2020-07: 9 reports for this device; peer average 5.4/device2020-08: 12 reports for this device; peer average 4.57/device2020-09: 7 reports for this device; peer average 4.43/device2020-10: 10 reports for this device; peer average 5.14/device2020-11: 12 reports for this device; peer average 4.88/device2020-12: 11 reports for this device; peer average 5.08/device2021-01: 4 reports for this device; peer average 4.86/device2021-02: 14 reports for this device; peer average 5.1/device2021-03: 19 reports for this device; peer average 5.73/device2021-04: 8 reports for this device; peer average 4.56/device2021-05: 13 reports for this device; peer average 4.56/device2021-06: 7 reports for this device; peer average 5.43/device2021-07: 6 reports for this device; peer average 4.49/device2021-08: 7 reports for this device; peer average 4.87/device2021-09: 6 reports for this device; peer average 3.93/device2021-10: 10 reports for this device; peer average 3.19/device2021-11: 15 reports for this device; peer average 4.08/device2021-12: 12 reports for this device; peer average 3.67/device2022-01: 2 reports for this device; peer average 3.52/device2022-02: 11 reports for this device; peer average 3.15/device2022-03: 10 reports for this device; peer average 3.37/device2022-04: 5 reports for this device; peer average 3.75/device2022-05: 8 reports for this device; peer average 2.97/device2022-06: 10 reports for this device; peer average 4.16/device2022-07: 6 reports for this device; peer average 4.17/device2022-08: 3 reports for this device; peer average 4.26/device2022-09: 7 reports for this device; peer average 3.72/device2022-10: 4 reports for this device; peer average 4.13/device2022-11: 13 reports for this device; peer average 4.3/device2022-12: 18 reports for this device; peer average 4.24/device2023-01: 5 reports for this device; peer average 3.42/device2023-02: 2 reports for this device; peer average 3.95/device2023-03: 6 reports for this device; peer average 4.6/device2023-04: 17 reports for this device; peer average 4/device2023-05: 6 reports for this device; peer average 5.03/device2023-06: 19 reports for this device; peer average 3.99/device2023-07: 8 reports for this device; peer average 4.33/device2023-08: 8 reports for this device; peer average 3.73/device2023-09: 7 reports for this device; peer average 3.85/device2023-10: 15 reports for this device; peer average 3.6/device2023-11: 7 reports for this device; peer average 3.86/device2023-12: 11 reports for this device; peer average 3.34/device2024-01: 3 reports for this device; peer average 4.05/device2024-02: 3 reports for this device; peer average 4.64/device2024-03: 17 reports for this device; peer average 4.32/device2024-04: 15 reports for this device; peer average 4.26/device2024-05: 2 reports for this device; peer average 3.3/device2024-06: 8 reports for this device; peer average 3.43/device2024-07: 2 reports for this device; peer average 3.6/device2024-08: 11 reports for this device; peer average 3.6/device2024-09: 8 reports for this device; peer average 4.95/device2024-10: 11 reports for this device; peer average 4.01/device2024-11: 10 reports for this device; peer average 3.64/device2024-12: 6 reports for this device; peer average 3.46/device2025-01: 4 reports for this device; peer average 2.95/device2025-02: 4 reports for this device; peer average 6.82/device2025-03: 4 reports for this device; peer average 4.95/device2025-04: 2 reports for this device; peer average 3.08/device2025-05: 7 reports for this device; peer average 4.42/device2025-06: 3 reports for this device; peer average 3.56/device2025-07: 8 reports for this device; peer average 3.98/device2025-08: 9 reports for this device; peer average 3.5/device2025-09: 5 reports for this device; peer average 3.1/device2025-10: 3 reports for this device; peer average 3.8/device2025-11: 9 reports for this device; peer average 3.27/device2025-12: 9 reports for this device; peer average 3.46/device2026-01: 10 reports for this device; peer average 2.62/device2026-02: 11 reports for this device; peer average 3.38/device2026-03: 3 reports for this device; peer average 3.6/device2026-04: 7 reports for this device; peer average 5.25/device2026-05: 20 reports for this device; peer average 3.94/device2026-06: 0 reports for this device; peer average 4.1/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0194.2
2019-0273.58
2019-03216.27
2019-04105.47
2019-0573.92
2019-0664.13
2019-07144.17
2019-0875.32
2019-09154.17
2019-1074.24
2019-1195.24
2019-12215.06
2020-0184.4
2020-0283.92
2020-03104.79
2020-0424.51
2020-0502.98
2020-0675.68
2020-0795.4
2020-08124.57
2020-0974.43
2020-10105.14
2020-11124.88
2020-12115.08
2021-0144.86
2021-02145.1
2021-03195.73
2021-0484.56
2021-05134.56
2021-0675.43
2021-0764.49
2021-0874.87
2021-0963.93
2021-10103.19
2021-11154.08
2021-12123.67
2022-0123.52
2022-02113.15
2022-03103.37
2022-0453.75
2022-0582.97
2022-06104.16
2022-0764.17
2022-0834.26
2022-0973.72
2022-1044.13
2022-11134.3
2022-12184.24
2023-0153.42
2023-0223.95
2023-0364.6
2023-04174
2023-0565.03
2023-06193.99
2023-0784.33
2023-0883.73
2023-0973.85
2023-10153.6
2023-1173.86
2023-12113.34
2024-0134.05
2024-0234.64
2024-03174.32
2024-04154.26
2024-0523.3
2024-0683.43
2024-0723.6
2024-08113.6
2024-0984.95
2024-10114.01
2024-11103.64
2024-1263.46
2025-0142.95
2025-0246.82
2025-0344.95
2025-0423.08
2025-0574.42
2025-0633.56
2025-0783.98
2025-0893.5
2025-0953.1
2025-1033.8
2025-1193.27
2025-1293.46
2026-01102.62
2026-02113.38
2026-0333.6
2026-0475.25
2026-05203.94
2026-0604.1
This device (reports/month)Average device in ERL (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
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  • 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