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AutoPlex, VertaPlex

Model 0605685000 · STRYKER CORPORATION · DI 07613154687152

JDZ — Mixer, Cement, For Clinical Use · Class I · 21 CFR 888.4210

LOD — Bone Cement · Class II · 21 CFR 888.3027

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 (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (1)

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: 1

91726352019-01: 0 reports for this device; peer average 4.17/device2019-02: 0 reports for this device; peer average 5.13/device2019-03: 0 reports for this device; peer average 3.17/device2019-04: 0 reports for this device; peer average 6.27/device2019-05: 0 reports for this device; peer average 3.42/device2019-06: 0 reports for this device; peer average 6.06/device2019-07: 0 reports for this device; peer average 5.21/device2019-08: 0 reports for this device; peer average 13.11/device2019-09: 0 reports for this device; peer average 16.23/device2019-10: 1 reports for this device; peer average 21.7/device2019-11: 0 reports for this device; peer average 34.57/device2019-12: 0 reports for this device; peer average 24.92/device2020-01: 0 reports for this device; peer average 20.06/device2020-02: 0 reports for this device; peer average 10.64/device2020-03: 0 reports for this device; peer average 10/device2020-04: 0 reports for this device; peer average 5.56/device2020-05: 0 reports for this device; peer average 7.33/device2020-06: 0 reports for this device; peer average 11.82/device2020-07: 0 reports for this device; peer average 4.86/device2020-08: 0 reports for this device; peer average 4.27/device2020-09: 0 reports for this device; peer average 6.18/device2020-10: 0 reports for this device; peer average 3.36/device2020-11: 0 reports for this device; peer average 18.22/device2020-12: 0 reports for this device; peer average 7/device2021-01: 0 reports for this device; peer average 4.87/device2021-02: 0 reports for this device; peer average 8.27/device2021-03: 0 reports for this device; peer average 10.31/device2021-04: 0 reports for this device; peer average 11.58/device2021-05: 0 reports for this device; peer average 7.07/device2021-06: 0 reports for this device; peer average 6.5/device2021-07: 0 reports for this device; peer average 7.8/device2021-08: 0 reports for this device; peer average 5/device2021-09: 0 reports for this device; peer average 3.63/device2021-10: 0 reports for this device; peer average 3.94/device2021-11: 0 reports for this device; peer average 3.64/device2021-12: 0 reports for this device; peer average 3.89/device2022-01: 0 reports for this device; peer average 3.5/device2022-02: 0 reports for this device; peer average 4.75/device2022-03: 0 reports for this device; peer average 5.7/device2022-04: 0 reports for this device; peer average 2.57/device2022-05: 0 reports for this device; peer average 3.08/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 4.13/device2022-08: 0 reports for this device; peer average 2.46/device2022-09: 0 reports for this device; peer average 1.85/device2022-10: 0 reports for this device; peer average 3.06/device2022-11: 0 reports for this device; peer average 2.92/device2022-12: 0 reports for this device; peer average 2.73/device2023-01: 0 reports for this device; peer average 2.2/device2023-02: 0 reports for this device; peer average 2.46/device2023-03: 0 reports for this device; peer average 4.7/device2023-04: 0 reports for this device; peer average 2.13/device2023-05: 0 reports for this device; peer average 2.33/device2023-06: 0 reports for this device; peer average 2.85/device2023-07: 0 reports for this device; peer average 2.88/device2023-08: 0 reports for this device; peer average 6.2/device2023-09: 0 reports for this device; peer average 4.08/device2023-10: 0 reports for this device; peer average 1.75/device2023-11: 0 reports for this device; peer average 2.08/device2023-12: 0 reports for this device; peer average 3.25/device2024-01: 0 reports for this device; peer average 4/device2024-02: 0 reports for this device; peer average 4.44/device2024-03: 0 reports for this device; peer average 2.31/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 4/device2024-06: 0 reports for this device; peer average 4.1/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 3.14/device2024-09: 0 reports for this device; peer average 2.75/device2024-10: 0 reports for this device; peer average 3.2/device2024-11: 0 reports for this device; peer average 3.33/device2024-12: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 1.93/device2025-02: 0 reports for this device; peer average 3.25/device2025-03: 0 reports for this device; peer average 2.79/device2025-04: 0 reports for this device; peer average 1.83/device2025-05: 0 reports for this device; peer average 2.82/device2025-06: 0 reports for this device; peer average 2.31/device2025-07: 0 reports for this device; peer average 2.38/device2025-08: 0 reports for this device; peer average 1.4/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 2.3/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 3.13/device2026-02: 0 reports for this device; peer average 2.29/device2026-03: 0 reports for this device; peer average 10.27/device2026-04: 0 reports for this device; peer average 13.78/device2026-05: 0 reports for this device; peer average 4/device2026-06: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.17
2019-0205.13
2019-0303.17
2019-0406.27
2019-0503.42
2019-0606.06
2019-0705.21
2019-08013.11
2019-09016.23
2019-10121.7
2019-11034.57
2019-12024.92
2020-01020.06
2020-02010.64
2020-03010
2020-0405.56
2020-0507.33
2020-06011.82
2020-0704.86
2020-0804.27
2020-0906.18
2020-1003.36
2020-11018.22
2020-1207
2021-0104.87
2021-0208.27
2021-03010.31
2021-04011.58
2021-0507.07
2021-0606.5
2021-0707.8
2021-0805
2021-0903.63
2021-1003.94
2021-1103.64
2021-1203.89
2022-0103.5
2022-0204.75
2022-0305.7
2022-0402.57
2022-0503.08
2022-0603
2022-0704.13
2022-0802.46
2022-0901.85
2022-1003.06
2022-1102.92
2022-1202.73
2023-0102.2
2023-0202.46
2023-0304.7
2023-0402.13
2023-0502.33
2023-0602.85
2023-0702.88
2023-0806.2
2023-0904.08
2023-1001.75
2023-1102.08
2023-1203.25
2024-0104
2024-0204.44
2024-0302.31
2024-0401.83
2024-0504
2024-0604.1
2024-0702
2024-0803.14
2024-0902.75
2024-1003.2
2024-1103.33
2024-1203
2025-0101.93
2025-0203.25
2025-0302.79
2025-0401.83
2025-0502.82
2025-0602.31
2025-0702.38
2025-0801.4
2025-0901.67
2025-1002.3
2025-1102
2025-1202
2026-0103.13
2026-0202.29
2026-03010.27
2026-04013.78
2026-0504
2026-0602
This device (reports/month)Average device in JDZ, LOD (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