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VADER Pedicle System, Torque Wrench, Hudson Coupling, 12 Nm
Model 42-702 · icotec AG · DI 07640164844589
NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2022-11-03
Z-0728-2023
Class II
Open, Classified
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
code info di
Adverse-event reports — MAUDE (5)
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: 3 · Injury: 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.15
2019-02
0
2.14
2019-03
0
1.93
2019-04
0
2.11
2019-05
0
2.3
2019-06
0
2.57
2019-07
0
1.67
2019-08
0
3
2019-09
0
1.75
2019-10
0
1.92
2019-11
0
2.44
2019-12
0
1.59
2020-01
0
2.43
2020-02
0
2.23
2020-03
0
2.38
2020-04
0
1.6
2020-05
0
2.71
2020-06
0
1.75
2020-07
0
2.06
2020-08
0
2.08
2020-09
0
2.52
2020-10
0
2.75
2020-11
0
2.36
2020-12
0
1.97
2021-01
0
2.4
2021-02
0
1.89
2021-03
0
2.61
2021-04
0
2.4
2021-05
0
2
2021-06
0
2.4
2021-07
0
2.27
2021-08
0
2.02
2021-09
0
1.95
2021-10
0
2.57
2021-11
0
2.35
2021-12
0
2.54
2022-01
0
2.18
2022-02
0
2.12
2022-03
0
1.9
2022-04
0
2.06
2022-05
0
1.9
2022-06
0
2.09
2022-07
0
4.92
2022-08
0
1.8
2022-09
0
2.66
2022-10
0
1.61
2022-11
0
1.8
2022-12
0
2.27
2023-01
0
1.97
2023-02
0
1.85
2023-03
0
1.64
2023-04
0
1.92
2023-05
0
1.56
2023-06
0
1.75
2023-07
0
2.05
2023-08
0
2.22
2023-09
0
2.61
2023-10
0
2.69
2023-11
0
2.46
2023-12
2
1.74
2024-01
3
2.44
2024-02
0
2.29
2024-03
0
3.6
2024-04
0
1.7
2024-05
0
3.68
2024-06
0
3.14
2024-07
0
1.96
2024-08
0
2
2024-09
0
3.67
2024-10
0
2.27
2024-11
0
2.18
2024-12
0
2.1
2025-01
0
2.32
2025-02
0
2.66
2025-03
0
2.4
2025-04
0
2.39
2025-05
0
2.64
2025-06
0
2.25
2025-07
0
1.9
2025-08
0
2.02
2025-09
0
1.81
2025-10
0
1.81
2025-11
0
2.03
2025-12
0
2.7
2026-01
0
2.28
2026-02
0
2.42
2026-03
0
2.37
2026-04
0
1.94
2026-05
0
2.28
2026-06
0
3.87
This device (reports/month)Average device in NKB (reports/device/month)