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FMS
Model 283812 · Medos International Sàrl · DI 10886705030743
HRX — Arthroscope · Class II · 21 CFR 888.1100
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2015-11-20
Z-0656-2016
Class II
Terminated
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
k number procode
2015-11-20
Z-0657-2016
Class II
Terminated
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
k number procode
Adverse-event reports — MAUDE (635)
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: 635
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
13.41
2019-02
0
3.29
2019-03
0
3.78
2019-04
0
4.27
2019-05
0
4.18
2019-06
0
3.67
2019-07
0
3.38
2019-08
0
3.9
2019-09
0
4.55
2019-10
0
5.02
2019-11
0
4.63
2019-12
0
5.21
2020-01
0
5.18
2020-02
0
5.84
2020-03
0
5.61
2020-04
0
5
2020-05
0
3.51
2020-06
0
5.69
2020-07
0
6.15
2020-08
0
5.71
2020-09
0
7.49
2020-10
0
8.72
2020-11
0
5.95
2020-12
0
8.86
2021-01
0
6.31
2021-02
0
5.77
2021-03
0
7.8
2021-04
1
6.1
2021-05
0
5.63
2021-06
0
5.7
2021-07
0
4.96
2021-08
0
5.25
2021-09
1
3.47
2021-10
3
5.1
2021-11
2
3.78
2021-12
5
5.41
2022-01
1
4.97
2022-02
0
3.74
2022-03
8
4.39
2022-04
1
4.17
2022-05
11
4.13
2022-06
5
4.35
2022-07
3
4.38
2022-08
1
4.33
2022-09
4
4.16
2022-10
5
4.1
2022-11
4
4.7
2022-12
1
4.67
2023-01
3
5.09
2023-02
3
4.36
2023-03
7
5.24
2023-04
10
4.82
2023-05
5
4.84
2023-06
3
4.5
2023-07
1
4.29
2023-08
12
5.05
2023-09
4
4.83
2023-10
13
4.41
2023-11
17
7.93
2023-12
13
8.8
2024-01
5
6.2
2024-02
10
6.57
2024-03
4
5.26
2024-04
5
5.97
2024-05
11
8.82
2024-06
20
8.82
2024-07
7
4.91
2024-08
8
4.86
2024-09
15
4.76
2024-10
11
6.15
2024-11
25
5.22
2024-12
10
7.58
2025-01
25
8.91
2025-02
19
6.11
2025-03
17
5.08
2025-04
26
5.43
2025-05
19
5.98
2025-06
21
5.09
2025-07
22
5.28
2025-08
20
4.37
2025-09
8
4.58
2025-10
15
5.09
2025-11
40
5.68
2025-12
17
5.94
2026-01
35
5.53
2026-02
16
5.56
2026-03
16
5.59
2026-04
19
7
2026-05
6
4.7
2026-06
16
4.85
This device (reports/month)Average device in HRX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K954465 — cited as predicate by K093409, K093471, K130169, K131191, K132883
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl