Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

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 (14)

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: 14

12232021-02: 2 reports for this device2021-10: 1 reports for this device2021-12: 2 reports for this device2022-03: 3 reports for this device2022-04: 1 reports for this device2022-06: 1 reports for this device2023-02: 1 reports for this device2024-01: 1 reports for this device2025-06: 1 reports for this device2026-04: 1 reports for this device02101203040602010604
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-022—
2021-101—
2021-122—
2022-033—
2022-041—
2022-061—
2023-021—
2024-011—
2025-061—
2026-041—
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.