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"""2.0/2.4MM"" FRACTURE SYSTEM"
Model 01-9728 · BIOMET MICROFIXATION, INC · DI 00841036018443
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
JEY — Plate, Bone · Class II · 21 CFR 872.4760
UDILibrary device dossier · generated 2026-09-07 · 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
1.88
2019-02
0
1.53
2019-03
0
2.05
2019-04
0
2.46
2019-05
0
1.91
2019-06
0
1.6
2019-07
0
1.7
2019-08
0
1.59
2019-09
0
1.7
2019-10
0
1.69
2019-11
0
1.78
2019-12
0
2.05
2020-01
0
2.27
2020-02
0
1.31
2020-03
0
1.72
2020-04
0
1.99
2020-05
0
1.88
2020-06
0
1.94
2020-07
0
1.97
2020-08
0
2.31
2020-09
0
2.65
2020-10
0
1.99
2020-11
0
2.2
2020-12
0
2.23
2021-01
0
1.81
2021-02
0
1.82
2021-03
0
2.12
2021-04
0
2.92
2021-05
0
2.79
2021-06
0
2.03
2021-07
0
2.17
2021-08
0
2.05
2021-09
0
1.97
2021-10
0
2.04
2021-11
0
2.04
2021-12
0
2.53
2022-01
0
2.75
2022-02
0
2.17
2022-03
0
2.05
2022-04
0
2.09
2022-05
0
1.93
2022-06
0
2.38
2022-07
0
2.24
2022-08
0
2.04
2022-09
0
2.3
2022-10
0
3.36
2022-11
0
2.86
2022-12
0
2.99
2023-01
0
2.54
2023-02
0
2.72
2023-03
0
2.92
2023-04
0
2.98
2023-05
0
4.05
2023-06
0
3.21
2023-07
0
2.51
2023-08
0
2.35
2023-09
0
2.17
2023-10
0
2.33
2023-11
0
2.18
2023-12
0
2.33
2024-01
0
2.15
2024-02
0
1.94
2024-03
0
1.89
2024-04
0
2.18
2024-05
0
1.97
2024-06
0
2.28
2024-07
0
2.13
2024-08
0
2.18
2024-09
0
1.71
2024-10
0
2.31
2024-11
0
1.69
2024-12
0
2.72
2025-01
0
1.61
2025-02
0
1.7
2025-03
0
2.61
2025-04
0
1.83
2025-05
0
2.11
2025-06
0
1.77
2025-07
0
2.29
2025-08
0
2.13
2025-09
0
1.73
2025-10
0
2.05
2025-11
0
1.85
2025-12
0
2.9
2026-01
0
1.65
2026-02
0
2.05
2026-03
0
2.74
2026-04
0
2.49
2026-05
0
2.05
2026-06
0
2.16
This device (reports/month)Average device in HRS, JEY (reports/device/month)