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VERSATILE SCREW SYSTEM
Model 348643 · Biomet Orthopedics, LLC · DI 00880304419933
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
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
2.68
2019-02
0
1.71
2019-03
0
1.81
2019-04
0
2.28
2019-05
0
1.83
2019-06
0
1.85
2019-07
0
1.93
2019-08
0
1.94
2019-09
0
2
2019-10
0
1.78
2019-11
0
2.09
2019-12
0
2.4
2020-01
0
2.46
2020-02
0
1.46
2020-03
0
1.93
2020-04
0
2.1
2020-05
0
1.89
2020-06
0
2.12
2020-07
0
2.42
2020-08
0
2.55
2020-09
0
2.62
2020-10
0
2.34
2020-11
0
2.95
2020-12
0
2.81
2021-01
0
2.03
2021-02
0
2.31
2021-03
0
2.58
2021-04
0
3.02
2021-05
0
2.73
2021-06
0
2.31
2021-07
0
2.41
2021-08
0
2.22
2021-09
0
2.55
2021-10
0
2.46
2021-11
0
2.56
2021-12
0
2.62
2022-01
0
3.34
2022-02
0
2.42
2022-03
0
2.27
2022-04
0
2.29
2022-05
0
2.42
2022-06
0
2.39
2022-07
0
2.46
2022-08
0
2.49
2022-09
0
2.81
2022-10
0
3.12
2022-11
0
2.89
2022-12
0
4.31
2023-01
0
2.79
2023-02
0
2.8
2023-03
0
3.14
2023-04
0
3.07
2023-05
0
3.62
2023-06
0
3.17
2023-07
0
2.51
2023-08
0
2.51
2023-09
0
2.42
2023-10
0
2.58
2023-11
0
2.37
2023-12
0
2.83
2024-01
0
2.97
2024-02
0
2.13
2024-03
0
2.61
2024-04
0
2.56
2024-05
0
2.55
2024-06
0
2.75
2024-07
0
2.73
2024-08
0
2.4
2024-09
0
2.41
2024-10
0
2.62
2024-11
0
2.43
2024-12
0
3.17
2025-01
0
2.77
2025-02
0
2.53
2025-03
0
2.7
2025-04
0
2.7
2025-05
0
2.83
2025-06
0
2.53
2025-07
0
2.67
2025-08
0
2.75
2025-09
0
2.61
2025-10
0
2.83
2025-11
0
2.61
2025-12
0
3.46
2026-01
0
2.85
2026-02
0
3.01
2026-03
0
3.32
2026-04
0
3.04
2026-05
0
3.4
2026-06
0
3.11
This device (reports/month)Average device in HRS, HWC, MAI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC