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Unnamed device

FX Shoulder Solutions

UDILibrary device dossier · generated 2026-09-13 · 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 (21)

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: 21

12342021-02: 1 reports for this device2021-03: 1 reports for this device2021-05: 2 reports for this device2021-08: 2 reports for this device2021-10: 1 reports for this device2021-12: 1 reports for this device2022-01: 3 reports for this device2022-04: 4 reports for this device2022-07: 1 reports for this device2022-08: 1 reports for this device2022-12: 1 reports for this device2023-05: 1 reports for this device2024-11: 1 reports for this device2026-05: 1 reports for this device0203050810120104070812051105
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-021—
2021-031—
2021-052—
2021-082—
2021-101—
2021-121—
2022-013—
2022-044—
2022-071—
2022-081—
2022-121—
2023-051—
2024-111—
2026-051—
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

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