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PRO

Model 703966 · Stryker GmbH · DI 07613252719861

LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540

UDILibrary device dossier · generated 2026-09-11 · 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 (123)

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: 98 · Injury: 25

25792019-01: 2 reports for this device; peer average 2.43/device2019-02: 0 reports for this device; peer average 2.31/device2019-03: 2 reports for this device; peer average 2.25/device2019-04: 0 reports for this device; peer average 2.08/device2019-05: 0 reports for this device; peer average 2.21/device2019-06: 2 reports for this device; peer average 2.28/device2019-07: 0 reports for this device; peer average 2.37/device2019-08: 0 reports for this device; peer average 2.23/device2019-09: 1 reports for this device; peer average 2.68/device2019-10: 2 reports for this device; peer average 2.1/device2019-11: 0 reports for this device; peer average 2.09/device2019-12: 0 reports for this device; peer average 2.29/device2020-01: 0 reports for this device; peer average 2.34/device2020-02: 0 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.14/device2020-04: 0 reports for this device; peer average 2.25/device2020-05: 0 reports for this device; peer average 2.09/device2020-06: 0 reports for this device; peer average 2.65/device2020-07: 3 reports for this device; peer average 3.62/device2020-08: 0 reports for this device; peer average 3.36/device2020-09: 3 reports for this device; peer average 3.49/device2020-10: 3 reports for this device; peer average 4.02/device2020-11: 0 reports for this device; peer average 3.63/device2020-12: 0 reports for this device; peer average 3.57/device2021-01: 0 reports for this device; peer average 3.73/device2021-02: 0 reports for this device; peer average 3.67/device2021-03: 9 reports for this device; peer average 3.23/device2021-04: 6 reports for this device; peer average 3.49/device2021-05: 0 reports for this device; peer average 3.18/device2021-06: 0 reports for this device; peer average 3.03/device2021-07: 9 reports for this device; peer average 2.66/device2021-08: 0 reports for this device; peer average 3.22/device2021-09: 0 reports for this device; peer average 2.79/device2021-10: 3 reports for this device; peer average 2.52/device2021-11: 3 reports for this device; peer average 3.11/device2021-12: 1 reports for this device; peer average 2.67/device2022-01: 0 reports for this device; peer average 2.6/device2022-02: 0 reports for this device; peer average 3.13/device2022-03: 0 reports for this device; peer average 3.17/device2022-04: 0 reports for this device; peer average 3.52/device2022-05: 3 reports for this device; peer average 3.71/device2022-06: 0 reports for this device; peer average 2.82/device2022-07: 3 reports for this device; peer average 2.5/device2022-08: 3 reports for this device; peer average 2.59/device2022-09: 3 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 3.08/device2022-11: 3 reports for this device; peer average 3.6/device2022-12: 0 reports for this device; peer average 3.74/device2023-01: 0 reports for this device; peer average 4.57/device2023-02: 0 reports for this device; peer average 3.11/device2023-03: 0 reports for this device; peer average 3.63/device2023-04: 0 reports for this device; peer average 3.08/device2023-05: 6 reports for this device; peer average 3.19/device2023-06: 0 reports for this device; peer average 3.19/device2023-07: 0 reports for this device; peer average 2.85/device2023-08: 2 reports for this device; peer average 2.89/device2023-09: 2 reports for this device; peer average 2.22/device2023-10: 4 reports for this device; peer average 2.4/device2023-11: 8 reports for this device; peer average 3.21/device2023-12: 0 reports for this device; peer average 3.04/device2024-01: 2 reports for this device; peer average 2.84/device2024-02: 2 reports for this device; peer average 3.03/device2024-03: 0 reports for this device; peer average 2.79/device2024-04: 0 reports for this device; peer average 3.59/device2024-05: 2 reports for this device; peer average 3.57/device2024-06: 0 reports for this device; peer average 3.68/device2024-07: 0 reports for this device; peer average 2.83/device2024-08: 0 reports for this device; peer average 2.74/device2024-09: 0 reports for this device; peer average 3.06/device2024-10: 0 reports for this device; peer average 3.11/device2024-11: 0 reports for this device; peer average 2.81/device2024-12: 0 reports for this device; peer average 2.56/device2025-01: 0 reports for this device; peer average 2.86/device2025-02: 0 reports for this device; peer average 4.24/device2025-03: 0 reports for this device; peer average 5.06/device2025-04: 2 reports for this device; peer average 2.79/device2025-05: 4 reports for this device; peer average 2.85/device2025-06: 0 reports for this device; peer average 2.78/device2025-07: 0 reports for this device; peer average 2.56/device2025-08: 3 reports for this device; peer average 2.6/device2025-09: 3 reports for this device; peer average 2.15/device2025-10: 2 reports for this device; peer average 2.32/device2025-11: 6 reports for this device; peer average 2.66/device2025-12: 0 reports for this device; peer average 3.79/device2026-01: 1 reports for this device; peer average 3.54/device2026-02: 2 reports for this device; peer average 3.48/device2026-03: 0 reports for this device; peer average 3.22/device2026-04: 4 reports for this device; peer average 3.13/device2026-05: 1 reports for this device; peer average 2.6/device2026-06: 3 reports for this device; peer average 3.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0122.43
2019-0202.31
2019-0322.25
2019-0402.08
2019-0502.21
2019-0622.28
2019-0702.37
2019-0802.23
2019-0912.68
2019-1022.1
2019-1102.09
2019-1202.29
2020-0102.34
2020-0202.07
2020-0302.14
2020-0402.25
2020-0502.09
2020-0602.65
2020-0733.62
2020-0803.36
2020-0933.49
2020-1034.02
2020-1103.63
2020-1203.57
2021-0103.73
2021-0203.67
2021-0393.23
2021-0463.49
2021-0503.18
2021-0603.03
2021-0792.66
2021-0803.22
2021-0902.79
2021-1032.52
2021-1133.11
2021-1212.67
2022-0102.6
2022-0203.13
2022-0303.17
2022-0403.52
2022-0533.71
2022-0602.82
2022-0732.5
2022-0832.59
2022-0932.82
2022-1003.08
2022-1133.6
2022-1203.74
2023-0104.57
2023-0203.11
2023-0303.63
2023-0403.08
2023-0563.19
2023-0603.19
2023-0702.85
2023-0822.89
2023-0922.22
2023-1042.4
2023-1183.21
2023-1203.04
2024-0122.84
2024-0223.03
2024-0302.79
2024-0403.59
2024-0523.57
2024-0603.68
2024-0702.83
2024-0802.74
2024-0903.06
2024-1003.11
2024-1102.81
2024-1202.56
2025-0102.86
2025-0204.24
2025-0305.06
2025-0422.79
2025-0542.85
2025-0602.78
2025-0702.56
2025-0832.6
2025-0932.15
2025-1022.32
2025-1162.66
2025-1203.79
2026-0113.54
2026-0223.48
2026-0303.22
2026-0443.13
2026-0512.6
2026-0633.35
This device (reports/month)Average device in LXH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Stryker GmbH

  • 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 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
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