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1.5MM REUNITE PN INSTR
Model 450005 · Biomet Orthopedics, LLC · DI 00880304377325
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-14 · 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
4.79
2019-02
0
2.07
2019-03
0
2.03
2019-04
0
2.11
2019-05
0
2.27
2019-06
0
2.26
2019-07
0
2.15
2019-08
0
2.32
2019-09
0
3.19
2019-10
0
2.84
2019-11
0
2.83
2019-12
0
2.89
2020-01
0
2.66
2020-02
0
1.83
2020-03
0
2.54
2020-04
0
3.37
2020-05
0
2.34
2020-06
0
2.97
2020-07
0
2.68
2020-08
0
3.06
2020-09
0
2.67
2020-10
0
3.08
2020-11
0
4.28
2020-12
0
3.94
2021-01
0
3.49
2021-02
0
2.78
2021-03
0
3.18
2021-04
0
3.77
2021-05
0
3.3
2021-06
0
2.88
2021-07
0
2.64
2021-08
0
2.87
2021-09
0
3.44
2021-10
0
3.41
2021-11
0
3.44
2021-12
0
3.17
2022-01
0
4.08
2022-02
0
3.05
2022-03
0
3.32
2022-04
0
3.39
2022-05
0
2.97
2022-06
0
2.88
2022-07
0
3.13
2022-08
0
3.48
2022-09
0
3.15
2022-10
0
3.7
2022-11
0
2.51
2022-12
0
3.46
2023-01
0
3.63
2023-02
0
2.95
2023-03
0
3.33
2023-04
0
3.73
2023-05
0
3.56
2023-06
0
3.82
2023-07
0
3.1
2023-08
0
3.43
2023-09
0
3.42
2023-10
0
3.26
2023-11
0
3.69
2023-12
0
3.84
2024-01
0
4.05
2024-02
0
3.08
2024-03
0
3.58
2024-04
0
3.67
2024-05
0
3.24
2024-06
0
3.68
2024-07
0
3.39
2024-08
0
3.01
2024-09
0
3.82
2024-10
0
3.58
2024-11
0
3.76
2024-12
0
4.15
2025-01
0
4.48
2025-02
0
3.43
2025-03
0
3.59
2025-04
0
3.69
2025-05
0
3.88
2025-06
0
3.84
2025-07
0
4.16
2025-08
0
4.2
2025-09
0
3.77
2025-10
0
3.95
2025-11
0
4.36
2025-12
0
5.19
2026-01
0
5.07
2026-02
0
4.85
2026-03
0
4.72
2026-04
0
4.84
2026-05
0
6
2026-06
0
5.65
This device (reports/month)Average device in HTY, MAI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC