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Unnamed device

FX Shoulder Solutions

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 (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (85)

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: 85

3710132021-02: 2 reports for this device2021-04: 1 reports for this device2021-08: 1 reports for this device2021-09: 1 reports for this device2021-10: 3 reports for this device2021-12: 4 reports for this device2022-01: 2 reports for this device2022-03: 13 reports for this device2022-04: 7 reports for this device2022-06: 3 reports for this device2022-12: 1 reports for this device2023-01: 2 reports for this device2023-03: 1 reports for this device2023-05: 2 reports for this device2023-06: 3 reports for this device2023-07: 4 reports for this device2023-08: 1 reports for this device2023-10: 1 reports for this device2023-11: 2 reports for this device2023-12: 2 reports for this device2024-02: 1 reports for this device2024-04: 1 reports for this device2024-05: 1 reports for this device2024-06: 1 reports for this device2024-07: 1 reports for this device2024-09: 1 reports for this device2024-10: 5 reports for this device2024-11: 2 reports for this device2025-01: 1 reports for this device2025-04: 1 reports for this device2025-06: 2 reports for this device2025-07: 1 reports for this device2025-10: 3 reports for this device2025-11: 1 reports for this device2026-01: 1 reports for this device2026-04: 1 reports for this device2026-05: 1 reports for this device2026-06: 4 reports for this device0204080910120103040612010305060708101112020405060709101101040607101101040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-022—
2021-041—
2021-081—
2021-091—
2021-103—
2021-124—
2022-012—
2022-0313—
2022-047—
2022-063—
2022-121—
2023-012—
2023-031—
2023-052—
2023-063—
2023-074—
2023-081—
2023-101—
2023-112—
2023-122—
2024-021—
2024-041—
2024-051—
2024-061—
2024-071—
2024-091—
2024-105—
2024-112—
2025-011—
2025-041—
2025-062—
2025-071—
2025-103—
2025-111—
2026-011—
2026-041—
2026-051—
2026-064—
This device (reports/month)Average device in its product code (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — FX Shoulder Solutions

Nothing in the loaded window.