Print-ready dossier — use your browser's print dialog to save as PDF.
Arthrex®
Model AR-2238B · ARTHREX, INC. · DI 00888867026193
GAS — Suture, Nonabsorbable, Synthetic, Polyester · Class II · 21 CFR 878.5000
KGS — Retention Device, Suture · Class I · 21 CFR 878.4930
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-16 · 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
4.88
2019-02
0
2.33
2019-03
0
2.32
2019-04
0
2.22
2019-05
0
2.34
2019-06
0
2.47
2019-07
0
2.14
2019-08
0
2.55
2019-09
0
3.08
2019-10
0
2.93
2019-11
0
2.82
2019-12
0
3.1
2020-01
0
2.83
2020-02
0
1.93
2020-03
0
2.77
2020-04
0
3.2
2020-05
0
2.54
2020-06
0
2.83
2020-07
0
2.71
2020-08
0
3.27
2020-09
0
2.82
2020-10
0
3.41
2020-11
0
4.62
2020-12
0
4.22
2021-01
0
3.49
2021-02
0
2.96
2021-03
0
3.38
2021-04
0
4.2
2021-05
0
3.6
2021-06
0
2.98
2021-07
0
2.8
2021-08
0
3.2
2021-09
0
3.68
2021-10
0
3.56
2021-11
0
3.71
2021-12
0
3.43
2022-01
0
4.33
2022-02
0
3.19
2022-03
0
3.39
2022-04
0
3.55
2022-05
0
3.05
2022-06
0
2.9
2022-07
0
3.44
2022-08
0
3.23
2022-09
0
3.25
2022-10
0
3.53
2022-11
0
2.58
2022-12
0
3.58
2023-01
0
3.88
2023-02
0
3.07
2023-03
0
3.26
2023-04
0
3.81
2023-05
0
3.6
2023-06
0
3.8
2023-07
0
3.1
2023-08
0
3.34
2023-09
0
3.6
2023-10
0
3.24
2023-11
0
3.45
2023-12
0
3.95
2024-01
0
4.12
2024-02
0
3.12
2024-03
0
3.54
2024-04
0
3.62
2024-05
0
3.28
2024-06
0
3.61
2024-07
0
3.45
2024-08
0
2.96
2024-09
0
3.81
2024-10
0
3.43
2024-11
0
3.62
2024-12
0
4.04
2025-01
0
4.24
2025-02
0
3.36
2025-03
0
3.7
2025-04
0
3.58
2025-05
0
3.86
2025-06
0
3.98
2025-07
0
4.07
2025-08
0
4.19
2025-09
0
3.83
2025-10
0
3.9
2025-11
0
4.19
2025-12
0
5.45
2026-01
0
4.77
2026-02
0
4.69
2026-03
0
4.66
2026-04
0
4.77
2026-05
0
5.81
2026-06
0
5.34
This device (reports/month)Average device in GAS, KGS, MAI (reports/device/month)