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EXPRESSEW
Model 214141 · Medos International Sàrl · DI 10886705020225
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-14 · 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 (1081)
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: 1054 · Injury: 27
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
11
2.43
2019-02
1
2.31
2019-03
9
2.25
2019-04
1
2.08
2019-05
3
2.21
2019-06
1
2.28
2019-07
8
2.37
2019-08
2
2.23
2019-09
8
2.68
2019-10
3
2.1
2019-11
3
2.09
2019-12
3
2.29
2020-01
2
2.34
2020-02
2
2.07
2020-03
3
2.14
2020-04
2
2.25
2020-05
4
2.09
2020-06
1
2.65
2020-07
3
3.62
2020-08
1
3.36
2020-09
3
3.49
2020-10
10
4.02
2020-11
2
3.63
2020-12
2
3.57
2021-01
1
3.73
2021-02
3
3.67
2021-03
0
3.23
2021-04
2
3.49
2021-05
1
3.18
2021-06
4
3.03
2021-07
0
2.66
2021-08
2
3.22
2021-09
6
2.79
2021-10
1
2.52
2021-11
1
3.11
2021-12
2
2.67
2022-01
2
2.6
2022-02
2
3.13
2022-03
3
3.17
2022-04
0
3.52
2022-05
4
3.71
2022-06
5
2.82
2022-07
1
2.5
2022-08
4
2.59
2022-09
1
2.82
2022-10
5
3.08
2022-11
90
3.6
2022-12
187
3.74
2023-01
271
4.57
2023-02
77
3.11
2023-03
106
3.63
2023-04
53
3.08
2023-05
16
3.19
2023-06
21
3.19
2023-07
3
2.85
2023-08
16
2.89
2023-09
4
2.22
2023-10
8
2.4
2023-11
2
3.21
2023-12
8
3.04
2024-01
2
2.84
2024-02
6
3.03
2024-03
5
2.79
2024-04
5
3.59
2024-05
2
3.57
2024-06
2
3.68
2024-07
2
2.83
2024-08
3
2.74
2024-09
0
3.06
2024-10
0
3.11
2024-11
1
2.81
2024-12
4
2.56
2025-01
4
2.86
2025-02
5
4.24
2025-03
4
5.06
2025-04
1
2.79
2025-05
3
2.85
2025-06
2
2.78
2025-07
6
2.56
2025-08
6
2.6
2025-09
1
2.15
2025-10
2
2.32
2025-11
1
2.66
2025-12
1
3.79
2026-01
2
3.54
2026-02
4
3.48
2026-03
1
3.22
2026-04
3
3.13
2026-05
0
2.6
2026-06
3
3.35
This device (reports/month)Average device in LXH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Medos International Sàrl