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32mm Glenosphere and Humeral Cup
Model 906-0027 · FX SOLUTIONS · DI 03701037314302
HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
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
2.23
2019-02
0
2.11
2019-03
0
2.04
2019-04
0
2.08
2019-05
0
2.21
2019-06
0
2.11
2019-07
0
2.1
2019-08
0
2.25
2019-09
0
2.31
2019-10
0
2.01
2019-11
0
1.87
2019-12
0
2.03
2020-01
0
2.17
2020-02
0
2.07
2020-03
0
2.14
2020-04
0
2
2020-05
0
1.95
2020-06
0
2.36
2020-07
0
2.99
2020-08
0
2.74
2020-09
0
2.8
2020-10
0
3.17
2020-11
0
2.92
2020-12
0
2.79
2021-01
0
3.1
2021-02
0
2.95
2021-03
0
2.71
2021-04
0
2.84
2021-05
0
2.67
2021-06
0
2.55
2021-07
0
2.49
2021-08
0
2.82
2021-09
0
2.51
2021-10
0
2.48
2021-11
0
2.61
2021-12
0
2.66
2022-01
0
2.68
2022-02
0
2.89
2022-03
0
2.96
2022-04
0
3.01
2022-05
0
2.85
2022-06
0
2.66
2022-07
0
2.45
2022-08
0
2.47
2022-09
0
2.47
2022-10
0
2.57
2022-11
0
2.85
2022-12
0
2.91
2023-01
0
3.2
2023-02
0
2.57
2023-03
0
2.79
2023-04
0
2.59
2023-05
0
2.5
2023-06
0
2.52
2023-07
0
2.4
2023-08
0
2.27
2023-09
0
1.81
2023-10
0
1.93
2023-11
0
2.37
2023-12
0
2.07
2024-01
0
2.21
2024-02
0
2.41
2024-03
0
2.06
2024-04
0
2.54
2024-05
0
2.67
2024-06
0
2.7
2024-07
0
2.08
2024-08
0
2.14
2024-09
0
2.32
2024-10
0
2.22
2024-11
0
2.06
2024-12
0
2.04
2025-01
0
2.17
2025-02
0
2.76
2025-03
0
2.92
2025-04
0
2.2
2025-05
0
2.18
2025-06
0
2.2
2025-07
0
1.96
2025-08
0
2.07
2025-09
0
1.71
2025-10
0
1.84
2025-11
0
2.04
2025-12
0
2.77
2026-01
0
2.34
2026-02
0
2.38
2026-03
0
2.25
2026-04
0
2.21
2026-05
0
1.97
2026-06
0
2.31
This device (reports/month)Average device in HSD, KWT, LXH, PHX (reports/device/month)