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Arthrex®
Model AR-8718CT-1512 · ARTHREX, INC. · DI 00888867516724
JDQ — Cerclage, Fixation · Class II · 21 CFR 888.3010
JDR — Staple, Fixation, Bone · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-08 · 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 (0)
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.
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
3.29
2019-02
0
1.54
2019-03
0
2.14
2019-04
0
2.64
2019-05
0
2.13
2019-06
0
1.92
2019-07
0
2.37
2019-08
0
2
2019-09
0
2.93
2019-10
0
2.52
2019-11
0
2.47
2019-12
0
2.58
2020-01
0
2.52
2020-02
0
2.36
2020-03
0
2.37
2020-04
0
3.32
2020-05
0
2.11
2020-06
0
3
2020-07
0
2.25
2020-08
0
2.77
2020-09
0
2.55
2020-10
0
2.7
2020-11
0
3.5
2020-12
0
3.17
2021-01
0
2.13
2021-02
0
2.89
2021-03
0
2.69
2021-04
0
2.33
2021-05
0
3
2021-06
0
2.88
2021-07
0
2.25
2021-08
0
2.23
2021-09
0
3.66
2021-10
0
2.46
2021-11
0
3.68
2021-12
0
2.86
2022-01
0
3.19
2022-02
0
2.96
2022-03
0
3.06
2022-04
0
2.76
2022-05
0
2.68
2022-06
0
2.39
2022-07
0
2.64
2022-08
0
3.36
2022-09
0
3.29
2022-10
0
4.65
2022-11
0
2.68
2022-12
0
2.88
2023-01
0
4.17
2023-02
0
2.76
2023-03
0
3.71
2023-04
0
3.28
2023-05
0
3.44
2023-06
0
4.76
2023-07
0
2.51
2023-08
0
2.82
2023-09
0
3.67
2023-10
0
2.54
2023-11
0
3.22
2023-12
0
2.94
2024-01
0
3.23
2024-02
0
2.35
2024-03
0
2.94
2024-04
0
2.74
2024-05
0
3.03
2024-06
0
3.81
2024-07
0
3.03
2024-08
0
3.65
2024-09
0
3.19
2024-10
0
3.2
2024-11
0
3.71
2024-12
0
3.54
2025-01
0
4.29
2025-02
0
2.65
2025-03
0
3.03
2025-04
0
3.1
2025-05
0
3.73
2025-06
0
3.45
2025-07
0
3.45
2025-08
0
3.68
2025-09
0
4
2025-10
0
3.5
2025-11
0
3.59
2025-12
0
3.94
2026-01
0
4.03
2026-02
0
4.15
2026-03
0
3.87
2026-04
0
3.43
2026-05
0
6.93
2026-06
0
4.52
This device (reports/month)Average device in JDQ, JDR (reports/device/month)