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Prime Series

Model 1125 · STRYKER CORPORATION · DI 07613327278323

INK — Stretcher, Wheeled, Powered · Class II · 21 CFR 890.3690

UDILibrary device dossier · generated 2026-09-12 · 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
2016-02-05Z-1184-2016Class IITerminatedThe hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events wek number procode

Adverse-event reports — MAUDE (64)

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: 62 · Injury: 2

24682019-01: 0 reports for this device; peer average 4.33/device2019-04: 1 reports for this device; peer average 3.33/device2019-06: 0 reports for this device; peer average 1/device2019-07: 1 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 2/device2019-10: 2 reports for this device; peer average 4.25/device2020-01: 3 reports for this device; peer average 4.5/device2020-02: 1 reports for this device; peer average 1/device2020-04: 3 reports for this device; peer average 3.75/device2020-07: 1 reports for this device; peer average 4/device2020-10: 2 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 1/device2021-01: 1 reports for this device; peer average 7.5/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 1/device2021-04: 3 reports for this device; peer average 3.25/device2021-06: 0 reports for this device; peer average 1/device2021-07: 2 reports for this device; peer average 4.5/device2021-08: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 2/device2021-10: 1 reports for this device; peer average 3.5/device2022-01: 2 reports for this device; peer average 4.25/device2022-02: 0 reports for this device; peer average 1/device2022-04: 2 reports for this device; peer average 4.5/device2022-05: 0 reports for this device; peer average 1/device2022-07: 1 reports for this device; peer average 5/device2022-10: 3 reports for this device; peer average 4.5/device2023-01: 3 reports for this device; peer average 5.5/device2023-02: 0 reports for this device; peer average 1/device2023-03: 1 reports for this device; peer average 1/device2023-04: 5 reports for this device; peer average 5.5/device2023-05: 0 reports for this device; peer average 1/device2023-07: 3 reports for this device; peer average 6.75/device2023-10: 3 reports for this device; peer average 6.25/device2024-01: 4 reports for this device; peer average 5.5/device2024-03: 0 reports for this device; peer average 1/device2024-04: 2 reports for this device; peer average 4.75/device2024-07: 1 reports for this device; peer average 5.5/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 6.67/device2024-12: 0 reports for this device; peer average 1/device2025-01: 4 reports for this device; peer average 5/device2025-03: 0 reports for this device; peer average 1/device2025-04: 1 reports for this device; peer average 5/device2025-06: 0 reports for this device; peer average 1/device2025-07: 2 reports for this device; peer average 1.5/device2025-10: 2 reports for this device; peer average 2.83/device2026-01: 3 reports for this device; peer average 2.2/device2026-04: 1 reports for this device; peer average 1.4/device01040607081001020407101101020304060708091001020405071001020304050710010304070910120103040607100104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.33
2019-0413.33
2019-0601
2019-0713.5
2019-0802
2019-1024.25
2020-0134.5
2020-0211
2020-0433.75
2020-0714
2020-1024
2020-1101
2021-0117.5
2021-0201.5
2021-0301
2021-0433.25
2021-0601
2021-0724.5
2021-0801.5
2021-0902
2021-1013.5
2022-0124.25
2022-0201
2022-0424.5
2022-0501
2022-0715
2022-1034.5
2023-0135.5
2023-0201
2023-0311
2023-0455.5
2023-0501
2023-0736.75
2023-1036.25
2024-0145.5
2024-0301
2024-0424.75
2024-0715.5
2024-0901
2024-1006.67
2024-1201
2025-0145
2025-0301
2025-0415
2025-0601
2025-0721.5
2025-1022.83
2026-0132.2
2026-0411.4
This device (reports/month)Average device in INK (reports/device/month)

Regulatory clearances

  • K140095 SESE 2014-05-20 (k number procode)

Predicate lineage

K140095 — cites (transitively): K022309 (d1), K922309 (d1)

Lineage extracted from public 510(k) summary text (heuristic).

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