TiN Coated Glenosphere
Model 115-3610 · FX SOLUTIONS · DI 03701037300800
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2023-08-08 | Z-0843-2024 | Class II | Open, Classified | Centered glenosphere box may contain an eccentric glenosphere. | k number procode |
Adverse-event reports — MAUDE (22)
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.
Injury: 22
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.1 |
| 2019-02 | 0 | 2.32 |
| 2019-03 | 0 | 1.9 |
| 2019-04 | 0 | 2.37 |
| 2019-05 | 0 | 2.59 |
| 2019-06 | 0 | 1.9 |
| 2019-07 | 0 | 2.22 |
| 2019-08 | 0 | 2.61 |
| 2019-09 | 0 | 1.98 |
| 2019-10 | 0 | 2.02 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 0 | 1.81 |
| 2020-01 | 0 | 2.03 |
| 2020-02 | 0 | 1.99 |
| 2020-03 | 0 | 2.77 |
| 2020-04 | 0 | 1.94 |
| 2020-05 | 0 | 1.92 |
| 2020-06 | 0 | 2.12 |
| 2020-07 | 0 | 2.78 |
| 2020-08 | 0 | 1.9 |
| 2020-09 | 0 | 2.01 |
| 2020-10 | 0 | 2.32 |
| 2020-11 | 0 | 1.97 |
| 2020-12 | 0 | 1.94 |
| 2021-01 | 0 | 2.64 |
| 2021-02 | 0 | 2.25 |
| 2021-03 | 0 | 2.39 |
| 2021-04 | 0 | 2.35 |
| 2021-05 | 0 | 2.25 |
| 2021-06 | 0 | 2.32 |
| 2021-07 | 0 | 2.38 |
| 2021-08 | 0 | 2.45 |
| 2021-09 | 0 | 2.35 |
| 2021-10 | 0 | 2.85 |
| 2021-11 | 0 | 2.36 |
| 2021-12 | 0 | 3.62 |
| 2022-01 | 0 | 3.42 |
| 2022-02 | 3 | 2.83 |
| 2022-03 | 3 | 3.44 |
| 2022-04 | 0 | 3.11 |
| 2022-05 | 0 | 2.47 |
| 2022-06 | 0 | 2.58 |
| 2022-07 | 0 | 2.41 |
| 2022-08 | 0 | 2.61 |
| 2022-09 | 0 | 2.37 |
| 2022-10 | 0 | 2.45 |
| 2022-11 | 0 | 2.38 |
| 2022-12 | 0 | 2.59 |
| 2023-01 | 0 | 2.04 |
| 2023-02 | 0 | 2.27 |
| 2023-03 | 0 | 2.22 |
| 2023-04 | 0 | 2.56 |
| 2023-05 | 0 | 2.29 |
| 2023-06 | 0 | 2.39 |
| 2023-07 | 0 | 2.16 |
| 2023-08 | 0 | 1.92 |
| 2023-09 | 0 | 1.71 |
| 2023-10 | 3 | 1.74 |
| 2023-11 | 1 | 1.84 |
| 2023-12 | 0 | 1.52 |
| 2024-01 | 1 | 1.74 |
| 2024-02 | 0 | 2.03 |
| 2024-03 | 1 | 1.8 |
| 2024-04 | 1 | 1.99 |
| 2024-05 | 0 | 1.73 |
| 2024-06 | 0 | 1.88 |
| 2024-07 | 0 | 1.69 |
| 2024-08 | 0 | 1.77 |
| 2024-09 | 1 | 1.77 |
| 2024-10 | 0 | 1.9 |
| 2024-11 | 0 | 1.72 |
| 2024-12 | 0 | 1.71 |
| 2025-01 | 0 | 1.77 |
| 2025-02 | 0 | 1.77 |
| 2025-03 | 1 | 2.04 |
| 2025-04 | 0 | 1.87 |
| 2025-05 | 0 | 1.94 |
| 2025-06 | 2 | 2.13 |
| 2025-07 | 0 | 1.89 |
| 2025-08 | 0 | 1.73 |
| 2025-09 | 2 | 1.54 |
| 2025-10 | 1 | 1.77 |
| 2025-11 | 0 | 1.78 |
| 2025-12 | 0 | 2.29 |
| 2026-01 | 1 | 2.02 |
| 2026-02 | 0 | 1.93 |
| 2026-03 | 0 | 1.88 |
| 2026-04 | 0 | 1.78 |
| 2026-05 | 0 | 1.86 |
| 2026-06 | 1 | 1.95 |
Regulatory clearances
- K191146 SESE 2020-07-15 (k number procode)
Predicate lineage
K191146 — cites (transitively): K150488 (d1), K152431 (d1), K162455 (d1), K163669 (d1), K053274 (d2), K123814 (d2), K130759 (d2), K132285 (d2), K140071 (d2), K030941 (d2), K082120 (d2), K100142 (d2), K122698 (d2), K060874 (d3), K111097 (d3), K992525 (d3), K994392 (d3) — cited as predicate by K254154
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — FX SOLUTIONS
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