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Unnamed device
FX Shoulder Solutions
UDILibrary device dossier · generated 2026-09-14 · 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 (38)
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: 38
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2021-02
1
—
2021-03
1
—
2021-05
1
—
2021-09
1
—
2021-11
1
—
2021-12
2
—
2022-01
3
—
2022-02
1
—
2022-04
1
—
2022-05
1
—
2023-04
1
—
2023-05
1
—
2023-08
1
—
2023-10
2
—
2023-12
1
—
2024-01
2
—
2024-04
1
—
2024-07
2
—
2024-08
1
—
2024-09
1
—
2024-10
2
—
2024-11
2
—
2025-02
1
—
2025-03
1
—
2025-05
1
—
2025-06
2
—
2025-07
1
—
2025-12
1
—
2026-06
1
—
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