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10MM CANNULATED DILATOR
Model 907800 · Biomet Orthopedics, LLC · DI 00880304409200
HWR — Driver, Prosthesis · Class I · 21 CFR 888.4540
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
5.38
2019-02
0
5.13
2019-03
0
3.47
2019-04
0
5.67
2019-05
0
4.9
2019-06
0
4.6
2019-07
0
4.26
2019-08
0
3.77
2019-09
0
3.47
2019-10
0
3.38
2019-11
0
4.86
2019-12
0
4.13
2020-01
0
4.92
2020-02
0
3.07
2020-03
0
4.94
2020-04
0
2.54
2020-05
0
3.07
2020-06
0
4.33
2020-07
0
3.28
2020-08
0
3.36
2020-09
0
4.41
2020-10
0
5
2020-11
0
5.43
2020-12
0
5.61
2021-01
0
3.89
2021-02
0
4.5
2021-03
0
5.42
2021-04
0
4.39
2021-05
0
4.38
2021-06
0
3.74
2021-07
0
4.4
2021-08
0
6
2021-09
0
3.3
2021-10
0
3.22
2021-11
0
5.09
2021-12
0
4.04
2022-01
0
3.37
2022-02
0
3.21
2022-03
0
6.82
2022-04
0
5.6
2022-05
0
3.58
2022-06
0
4.58
2022-07
0
4
2022-08
0
5.72
2022-09
0
4.8
2022-10
0
4.27
2022-11
0
6.11
2022-12
0
4.86
2023-01
0
5.71
2023-02
0
5.88
2023-03
0
8.4
2023-04
0
3
2023-05
0
5.09
2023-06
0
6.63
2023-07
0
5.18
2023-08
0
5.29
2023-09
0
6.46
2023-10
0
5.11
2023-11
0
4.85
2023-12
0
5.86
2024-01
0
5.2
2024-02
0
3.77
2024-03
0
3.28
2024-04
0
6.07
2024-05
0
2.87
2024-06
0
4
2024-07
0
2.89
2024-08
0
3.17
2024-09
0
3.93
2024-10
0
4.43
2024-11
0
2.85
2024-12
0
4.79
2025-01
0
4
2025-02
0
2.14
2025-03
0
3.37
2025-04
0
2.84
2025-05
0
5
2025-06
0
2.88
2025-07
0
4.14
2025-08
0
6.1
2025-09
0
2.48
2025-10
0
3.56
2025-11
0
5.96
2025-12
0
4.94
2026-01
0
3.4
2026-02
0
4.24
2026-03
0
5.2
2026-04
0
4.84
2026-05
0
3.96
2026-06
0
5.13
This device (reports/month)Average device in HWR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC