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ACUMED
Model FX-4001-S · Acumed LLC · DI 10806378067372
JEC — Component, Traction, Invasive · Class II · 21 CFR 888.3040
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 (6)
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.
Malfunction: 5 · Injury: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-03
0
1
2019-05
0
4
2019-09
0
1
2019-12
1
1
2020-01
0
3
2020-06
0
2
2020-07
1
1
2020-12
0
3
2021-11
1
1
2022-07
1
1
2023-04
2
1.8
2023-05
0
1.75
2024-04
0
1
2025-01
0
1
2025-10
0
1
2026-06
0
1
This device (reports/month)Average device in JEC (reports/device/month)