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Prime Series

Model 1115 · STRYKER CORPORATION · DI 07613327278217

FPO — Stretcher, Wheeled · Class II · 21 CFR 880.6910

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 (242)

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: 227 · Injury: 14 · Death: 1

4811152019-01: 5 reports for this device; peer average 2.41/device2019-02: 1 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 3/device2019-04: 6 reports for this device; peer average 2.46/device2019-05: 2 reports for this device; peer average 1.89/device2019-06: 0 reports for this device; peer average 2.33/device2019-07: 6 reports for this device; peer average 2.48/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 3 reports for this device; peer average 2.59/device2019-11: 0 reports for this device; peer average 1.8/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 8 reports for this device; peer average 2.8/device2020-02: 2 reports for this device; peer average 2.5/device2020-03: 1 reports for this device; peer average 1.17/device2020-04: 8 reports for this device; peer average 3/device2020-05: 0 reports for this device; peer average 2.8/device2020-06: 0 reports for this device; peer average 1.67/device2020-07: 6 reports for this device; peer average 2.92/device2020-08: 1 reports for this device; peer average 1.15/device2020-09: 1 reports for this device; peer average 1.5/device2020-10: 6 reports for this device; peer average 2.92/device2020-11: 4 reports for this device; peer average 2.25/device2020-12: 0 reports for this device; peer average 1/device2021-01: 15 reports for this device; peer average 4.96/device2021-02: 2 reports for this device; peer average 3.35/device2021-03: 0 reports for this device; peer average 1.67/device2021-04: 4 reports for this device; peer average 2.43/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 1.89/device2021-07: 6 reports for this device; peer average 2.47/device2021-08: 1 reports for this device; peer average 1.6/device2021-09: 0 reports for this device; peer average 1.2/device2021-10: 6 reports for this device; peer average 2.83/device2021-11: 0 reports for this device; peer average 1.17/device2021-12: 0 reports for this device; peer average 1.67/device2022-01: 5 reports for this device; peer average 2.72/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.75/device2022-04: 6 reports for this device; peer average 3.1/device2022-05: 0 reports for this device; peer average 2.33/device2022-06: 0 reports for this device; peer average 1/device2022-07: 7 reports for this device; peer average 3.23/device2022-08: 2 reports for this device; peer average 1.75/device2022-09: 0 reports for this device; peer average 4/device2022-10: 9 reports for this device; peer average 3.29/device2022-11: 1 reports for this device; peer average 1.43/device2022-12: 0 reports for this device; peer average 2/device2023-01: 6 reports for this device; peer average 3.16/device2023-02: 1 reports for this device; peer average 1.67/device2023-03: 0 reports for this device; peer average 2.3/device2023-04: 10 reports for this device; peer average 3.68/device2023-05: 0 reports for this device; peer average 2.33/device2023-06: 0 reports for this device; peer average 2.4/device2023-07: 8 reports for this device; peer average 3.68/device2023-08: 1 reports for this device; peer average 1.63/device2023-09: 1 reports for this device; peer average 1.77/device2023-10: 8 reports for this device; peer average 3.5/device2023-11: 0 reports for this device; peer average 2.5/device2023-12: 0 reports for this device; peer average 2.4/device2024-01: 12 reports for this device; peer average 3.57/device2024-02: 0 reports for this device; peer average 3.17/device2024-03: 1 reports for this device; peer average 1.71/device2024-04: 10 reports for this device; peer average 4.21/device2024-05: 0 reports for this device; peer average 1.43/device2024-06: 0 reports for this device; peer average 2.3/device2024-07: 13 reports for this device; peer average 3.51/device2024-08: 1 reports for this device; peer average 1.57/device2024-09: 0 reports for this device; peer average 7/device2024-10: 8 reports for this device; peer average 4/device2024-11: 0 reports for this device; peer average 5.43/device2024-12: 0 reports for this device; peer average 4.6/device2025-01: 10 reports for this device; peer average 3.77/device2025-02: 0 reports for this device; peer average 6.67/device2025-03: 0 reports for this device; peer average 8/device2025-04: 9 reports for this device; peer average 3.81/device2025-05: 1 reports for this device; peer average 6/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 3.23/device2025-08: 0 reports for this device; peer average 5.67/device2025-09: 0 reports for this device; peer average 5/device2025-10: 7 reports for this device; peer average 3.47/device2025-11: 0 reports for this device; peer average 5.67/device2025-12: 1 reports for this device; peer average 3.22/device2026-01: 3 reports for this device; peer average 3.13/device2026-02: 0 reports for this device; peer average 4.67/device2026-03: 0 reports for this device; peer average 5.11/device2026-04: 6 reports for this device; peer average 3.84/device2026-05: 1 reports for this device; peer average 10.43/device2026-06: 0 reports for this device; peer average 7.43/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0152.41
2019-0211.71
2019-0303
2019-0462.46
2019-0521.89
2019-0602.33
2019-0762.48
2019-0802
2019-0901
2019-1032.59
2019-1101.8
2019-1202.5
2020-0182.8
2020-0222.5
2020-0311.17
2020-0483
2020-0502.8
2020-0601.67
2020-0762.92
2020-0811.15
2020-0911.5
2020-1062.92
2020-1142.25
2020-1201
2021-01154.96
2021-0223.35
2021-0301.67
2021-0442.43
2021-0502
2021-0601.89
2021-0762.47
2021-0811.6
2021-0901.2
2021-1062.83
2021-1101.17
2021-1201.67
2022-0152.72
2022-0201
2022-0301.75
2022-0463.1
2022-0502.33
2022-0601
2022-0773.23
2022-0821.75
2022-0904
2022-1093.29
2022-1111.43
2022-1202
2023-0163.16
2023-0211.67
2023-0302.3
2023-04103.68
2023-0502.33
2023-0602.4
2023-0783.68
2023-0811.63
2023-0911.77
2023-1083.5
2023-1102.5
2023-1202.4
2024-01123.57
2024-0203.17
2024-0311.71
2024-04104.21
2024-0501.43
2024-0602.3
2024-07133.51
2024-0811.57
2024-0907
2024-1084
2024-1105.43
2024-1204.6
2025-01103.77
2025-0206.67
2025-0308
2025-0493.81
2025-0516
2025-0603
2025-0703.23
2025-0805.67
2025-0905
2025-1073.47
2025-1105.67
2025-1213.22
2026-0133.13
2026-0204.67
2026-0305.11
2026-0463.84
2026-05110.43
2026-0607.43
This device (reports/month)Average device in FPO (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