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1/4 TUBULAR PLATE - COLLARED
Model 934626008 · Biomet Orthopedics, LLC · DI 00887868124044
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020
HTN — Washer, Bolt Nut · Class II · 21 CFR 888.3030
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JDW — Pin, Fixation, Threaded · Class II · 21 CFR 888.3040
KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030
LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite · 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
2.18
2019-02
0
1.54
2019-03
0
1.68
2019-04
0
2.05
2019-05
0
1.64
2019-06
0
1.69
2019-07
0
1.84
2019-08
0
2
2019-09
0
1.69
2019-10
0
1.59
2019-11
0
1.91
2019-12
0
2.07
2020-01
0
2.24
2020-02
0
1.52
2020-03
0
1.71
2020-04
0
1.96
2020-05
0
1.8
2020-06
0
2.1
2020-07
0
2.27
2020-08
0
2.52
2020-09
0
2.48
2020-10
0
2.19
2020-11
0
2.76
2020-12
0
2.68
2021-01
0
2.1
2021-02
0
2.46
2021-03
0
2.66
2021-04
0
2.87
2021-05
0
3.15
2021-06
0
2.43
2021-07
0
2.24
2021-08
0
1.97
2021-09
0
2.21
2021-10
0
1.91
2021-11
0
2.57
2021-12
0
2.25
2022-01
0
2.89
2022-02
0
2.16
2022-03
0
2.08
2022-04
0
2.16
2022-05
0
2.23
2022-06
0
2.29
2022-07
0
2.08
2022-08
0
2.34
2022-09
0
2.56
2022-10
0
2.89
2022-11
0
2.85
2022-12
0
3.63
2023-01
0
2.66
2023-02
0
2.57
2023-03
0
2.83
2023-04
0
2.75
2023-05
0
3.3
2023-06
0
2.81
2023-07
0
2.16
2023-08
0
2.09
2023-09
0
1.97
2023-10
0
2.03
2023-11
0
1.98
2023-12
0
2.39
2024-01
0
2.38
2024-02
0
1.86
2024-03
0
2.08
2024-04
0
2.07
2024-05
0
2.19
2024-06
0
2.4
2024-07
0
2.11
2024-08
0
2.1
2024-09
0
2.05
2024-10
0
2.2
2024-11
0
1.94
2024-12
0
2.52
2025-01
0
2.14
2025-02
0
2.07
2025-03
0
2.17
2025-04
0
2.22
2025-05
0
2.29
2025-06
0
1.75
2025-07
0
2.13
2025-08
0
2.14
2025-09
0
1.88
2025-10
0
2.2
2025-11
0
2.02
2025-12
0
2.35
2026-01
0
2.15
2026-02
0
2.13
2026-03
0
2.54
2026-04
0
2.19
2026-05
0
2.44
2026-06
0
2.19
This device (reports/month)Average device in HRS, HSB, HTN, HTY, HWC, JDW, KTT, LXT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC