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CoLS PCL femoral guide V5
Model 264929 · FOURNITURES HOSPITALIERES INDUSTRIE · DI 03661489649295
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-07 · 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 (0)
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.94
2019-02
0
1.84
2019-03
0
2.03
2019-04
0
2.51
2019-05
0
2.23
2019-06
0
2.13
2019-07
0
2.57
2019-08
0
2.49
2019-09
0
2.27
2019-10
0
2.2
2019-11
0
3.38
2019-12
0
3.53
2020-01
0
3.46
2020-02
0
2.75
2020-03
0
2.72
2020-04
0
3.05
2020-05
0
2.37
2020-06
0
2.59
2020-07
0
3.06
2020-08
0
3.08
2020-09
0
2.93
2020-10
0
3.02
2020-11
0
3.98
2020-12
0
3.61
2021-01
0
2.66
2021-02
0
2.99
2021-03
0
3.06
2021-04
0
3.13
2021-05
0
3.07
2021-06
0
2.88
2021-07
0
2.94
2021-08
0
2.92
2021-09
0
2.98
2021-10
0
3.16
2021-11
0
2.94
2021-12
0
3.32
2022-01
0
3.38
2022-02
0
2.63
2022-03
0
2.77
2022-04
0
2.44
2022-05
0
2.92
2022-06
0
2.8
2022-07
0
2.63
2022-08
0
3.15
2022-09
0
3.2
2022-10
0
3.39
2022-11
0
2.94
2022-12
0
4.84
2023-01
0
2.96
2023-02
0
2.99
2023-03
0
3.4
2023-04
0
3.22
2023-05
0
3.83
2023-06
0
3.45
2023-07
0
2.95
2023-08
0
3.09
2023-09
0
3.17
2023-10
0
3.25
2023-11
0
3.04
2023-12
0
3.98
2024-01
0
4.09
2024-02
0
3.11
2024-03
0
3.55
2024-04
0
3.52
2024-05
0
4.51
2024-06
0
4.92
2024-07
0
3.21
2024-08
0
2.96
2024-09
0
3.37
2024-10
0
3.45
2024-11
0
3.07
2024-12
0
3.53
2025-01
0
3.54
2025-02
0
3.49
2025-03
0
3.3
2025-04
0
3.75
2025-05
0
4
2025-06
0
3.73
2025-07
0
3.53
2025-08
0
3.6
2025-09
0
3.21
2025-10
0
3.69
2025-11
0
3.61
2025-12
0
4.48
2026-01
0
3.69
2026-02
0
4.02
2026-03
0
4.16
2026-04
0
3.92
2026-05
0
4.13
2026-06
0
4.07
This device (reports/month)Average device in HWC, MBI (reports/device/month)