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VARIAX

Model 657314S · Stryker GmbH · DI 07613327086850

HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030

HTN — Washer, Bolt Nut · Class II · 21 CFR 888.3030

HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040

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 (78)

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: 61 · Injury: 17

25792019-01: 0 reports for this device; peer average 2.03/device2019-02: 0 reports for this device; peer average 1.58/device2019-03: 0 reports for this device; peer average 1.76/device2019-04: 0 reports for this device; peer average 2.29/device2019-05: 0 reports for this device; peer average 1.73/device2019-06: 0 reports for this device; peer average 1.74/device2019-07: 0 reports for this device; peer average 1.89/device2019-08: 0 reports for this device; peer average 1.84/device2019-09: 2 reports for this device; peer average 1.72/device2019-10: 0 reports for this device; peer average 1.63/device2019-11: 0 reports for this device; peer average 1.91/device2019-12: 0 reports for this device; peer average 2.26/device2020-01: 0 reports for this device; peer average 2.4/device2020-02: 3 reports for this device; peer average 1.49/device2020-03: 0 reports for this device; peer average 1.77/device2020-04: 3 reports for this device; peer average 1.93/device2020-05: 3 reports for this device; peer average 1.84/device2020-06: 0 reports for this device; peer average 2.03/device2020-07: 0 reports for this device; peer average 2.34/device2020-08: 3 reports for this device; peer average 2.44/device2020-09: 0 reports for this device; peer average 2.67/device2020-10: 0 reports for this device; peer average 2.1/device2020-11: 0 reports for this device; peer average 2.64/device2020-12: 0 reports for this device; peer average 2.38/device2021-01: 0 reports for this device; peer average 1.83/device2021-02: 0 reports for this device; peer average 2.18/device2021-03: 0 reports for this device; peer average 2.38/device2021-04: 3 reports for this device; peer average 2.74/device2021-05: 0 reports for this device; peer average 2.49/device2021-06: 0 reports for this device; peer average 2.14/device2021-07: 3 reports for this device; peer average 2.27/device2021-08: 0 reports for this device; peer average 2.01/device2021-09: 0 reports for this device; peer average 2.23/device2021-10: 0 reports for this device; peer average 2.05/device2021-11: 0 reports for this device; peer average 2.22/device2021-12: 3 reports for this device; peer average 2.29/device2022-01: 0 reports for this device; peer average 2.93/device2022-02: 0 reports for this device; peer average 2.15/device2022-03: 0 reports for this device; peer average 1.91/device2022-04: 9 reports for this device; peer average 2.05/device2022-05: 0 reports for this device; peer average 2.2/device2022-06: 0 reports for this device; peer average 2.26/device2022-07: 3 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 2.42/device2022-09: 3 reports for this device; peer average 2.69/device2022-10: 0 reports for this device; peer average 2.96/device2022-11: 0 reports for this device; peer average 2.98/device2022-12: 0 reports for this device; peer average 4.53/device2023-01: 0 reports for this device; peer average 2.64/device2023-02: 0 reports for this device; peer average 2.76/device2023-03: 0 reports for this device; peer average 3.04/device2023-04: 3 reports for this device; peer average 2.92/device2023-05: 0 reports for this device; peer average 3.6/device2023-06: 3 reports for this device; peer average 2.93/device2023-07: 0 reports for this device; peer average 2.24/device2023-08: 2 reports for this device; peer average 2.22/device2023-09: 0 reports for this device; peer average 2.02/device2023-10: 0 reports for this device; peer average 2.26/device2023-11: 6 reports for this device; peer average 1.96/device2023-12: 0 reports for this device; peer average 2.59/device2024-01: 2 reports for this device; peer average 2.6/device2024-02: 4 reports for this device; peer average 1.91/device2024-03: 0 reports for this device; peer average 2.2/device2024-04: 2 reports for this device; peer average 2.19/device2024-05: 1 reports for this device; peer average 2.32/device2024-06: 0 reports for this device; peer average 2.56/device2024-07: 0 reports for this device; peer average 2.46/device2024-08: 0 reports for this device; peer average 2.16/device2024-09: 2 reports for this device; peer average 2/device2024-10: 2 reports for this device; peer average 2.25/device2024-11: 0 reports for this device; peer average 1.94/device2024-12: 2 reports for this device; peer average 2.77/device2025-01: 2 reports for this device; peer average 2.05/device2025-02: 3 reports for this device; peer average 2.22/device2025-03: 0 reports for this device; peer average 2.34/device2025-04: 0 reports for this device; peer average 2.32/device2025-05: 0 reports for this device; peer average 2.52/device2025-06: 0 reports for this device; peer average 1.87/device2025-07: 2 reports for this device; peer average 2.18/device2025-08: 0 reports for this device; peer average 2.28/device2025-09: 0 reports for this device; peer average 1.98/device2025-10: 0 reports for this device; peer average 2.35/device2025-11: 2 reports for this device; peer average 2.02/device2025-12: 0 reports for this device; peer average 2.6/device2026-01: 0 reports for this device; peer average 1.98/device2026-02: 0 reports for this device; peer average 2.19/device2026-03: 2 reports for this device; peer average 2.81/device2026-04: 0 reports for this device; peer average 2.22/device2026-05: 0 reports for this device; peer average 2.44/device2026-06: 0 reports for this device; peer average 2.2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.03
2019-0201.58
2019-0301.76
2019-0402.29
2019-0501.73
2019-0601.74
2019-0701.89
2019-0801.84
2019-0921.72
2019-1001.63
2019-1101.91
2019-1202.26
2020-0102.4
2020-0231.49
2020-0301.77
2020-0431.93
2020-0531.84
2020-0602.03
2020-0702.34
2020-0832.44
2020-0902.67
2020-1002.1
2020-1102.64
2020-1202.38
2021-0101.83
2021-0202.18
2021-0302.38
2021-0432.74
2021-0502.49
2021-0602.14
2021-0732.27
2021-0802.01
2021-0902.23
2021-1002.05
2021-1102.22
2021-1232.29
2022-0102.93
2022-0202.15
2022-0301.91
2022-0492.05
2022-0502.2
2022-0602.26
2022-0732.21
2022-0802.42
2022-0932.69
2022-1002.96
2022-1102.98
2022-1204.53
2023-0102.64
2023-0202.76
2023-0303.04
2023-0432.92
2023-0503.6
2023-0632.93
2023-0702.24
2023-0822.22
2023-0902.02
2023-1002.26
2023-1161.96
2023-1202.59
2024-0122.6
2024-0241.91
2024-0302.2
2024-0422.19
2024-0512.32
2024-0602.56
2024-0702.46
2024-0802.16
2024-0922
2024-1022.25
2024-1101.94
2024-1222.77
2025-0122.05
2025-0232.22
2025-0302.34
2025-0402.32
2025-0502.52
2025-0601.87
2025-0722.18
2025-0802.28
2025-0901.98
2025-1002.35
2025-1122.02
2025-1202.6
2026-0101.98
2026-0202.19
2026-0322.81
2026-0402.22
2026-0502.44
2026-0602.2
This device (reports/month)Average device in HRS, HTN, HWC (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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  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
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  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
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