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Unnamed device

FX Shoulder Solutions

UDILibrary device dossier · generated 2026-09-12 · 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 (28)

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: 27 · Death: 1

13452021-03: 2 reports for this device2021-04: 1 reports for this device2021-05: 2 reports for this device2021-08: 2 reports for this device2021-09: 1 reports for this device2021-11: 1 reports for this device2021-12: 3 reports for this device2022-01: 3 reports for this device2022-02: 2 reports for this device2022-03: 5 reports for this device2022-04: 1 reports for this device2022-12: 1 reports for this device2023-05: 1 reports for this device2023-10: 1 reports for this device2023-11: 1 reports for this device2024-10: 1 reports for this device03040508091112010203041205101110
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-032—
2021-041—
2021-052—
2021-082—
2021-091—
2021-111—
2021-123—
2022-013—
2022-022—
2022-035—
2022-041—
2022-121—
2023-051—
2023-101—
2023-111—
2024-101—
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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