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Arthrex®
Model AR-7267T-1 · ARTHREX, INC. · DI 00888867280601
GAT — Suture, Nonabsorbable, Synthetic, Polyethylene · Class II · 21 CFR 878.5000
HTN — Washer, Bolt Nut · Class II · 21 CFR 888.3030
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JDQ — Cerclage, Fixation · Class II · 21 CFR 888.3010
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 (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
2.7
2019-02
0
2.25
2019-03
0
2.48
2019-04
0
2.92
2019-05
0
2.5
2019-06
0
2.25
2019-07
0
2.93
2019-08
0
2.76
2019-09
0
2.73
2019-10
0
2.55
2019-11
0
3.41
2019-12
0
3.71
2020-01
0
3.63
2020-02
0
2.63
2020-03
0
3.53
2020-04
0
3.61
2020-05
0
2.72
2020-06
0
2.81
2020-07
0
3.67
2020-08
0
3.46
2020-09
0
3.19
2020-10
0
3.42
2020-11
0
3.88
2020-12
0
3.64
2021-01
0
3.27
2021-02
0
3.81
2021-03
0
3.82
2021-04
0
4.17
2021-05
0
3.54
2021-06
0
3.19
2021-07
0
3.85
2021-08
0
3.19
2021-09
0
3.8
2021-10
0
3.96
2021-11
0
3.69
2021-12
0
4.07
2022-01
0
4.06
2022-02
0
3.84
2022-03
0
3.39
2022-04
0
2.78
2022-05
0
4.05
2022-06
0
2.99
2022-07
0
3.11
2022-08
0
4.22
2022-09
0
3.75
2022-10
0
4.28
2022-11
0
5.11
2022-12
0
6.48
2023-01
0
5.6
2023-02
0
5.68
2023-03
0
6.57
2023-04
0
5.32
2023-05
0
6.36
2023-06
0
6.96
2023-07
0
6.39
2023-08
0
7.04
2023-09
0
5.22
2023-10
0
6.67
2023-11
0
3.71
2023-12
0
6.06
2024-01
0
4.89
2024-02
0
5.84
2024-03
0
12.62
2024-04
0
17.46
2024-05
0
20.88
2024-06
0
21.68
2024-07
0
19.97
2024-08
0
9.99
2024-09
0
8.5
2024-10
0
6.57
2024-11
0
5.72
2024-12
0
5.3
2025-01
0
4.35
2025-02
0
3.94
2025-03
0
3.8
2025-04
0
4.5
2025-05
0
4.94
2025-06
0
4.44
2025-07
0
3.69
2025-08
0
3.73
2025-09
0
3.5
2025-10
0
4.13
2025-11
0
5.56
2025-12
0
4.55
2026-01
0
4.23
2026-02
0
5.67
2026-03
0
4.25
2026-04
0
4.09
2026-05
0
4.92
2026-06
0
4.6
This device (reports/month)Average device in GAT, HTN, HWC, JDQ (reports/device/month)