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Anspach Helix™
Model L-5B-HX-G1 · Synthes GmbH · DI 00845384018223
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
HBC — Motor, Drill, Electric · Class II · 21 CFR 882.4360
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
UDILibrary device dossier · generated 2026-09-06 · 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
3.11
2019-02
0
3.5
2019-03
0
6.32
2019-04
0
4.63
2019-05
0
3.87
2019-06
0
4.03
2019-07
0
3.7
2019-08
0
4.79
2019-09
0
3.79
2019-10
0
3.7
2019-11
0
4.54
2019-12
0
4.59
2020-01
0
3.93
2020-02
0
4.35
2020-03
0
4.77
2020-04
0
3.93
2020-05
0
2.91
2020-06
0
5.27
2020-07
0
4.72
2020-08
0
4
2020-09
0
4.46
2020-10
0
4.51
2020-11
0
4.54
2020-12
0
4.98
2021-01
0
4.05
2021-02
0
4.35
2021-03
0
5.04
2021-04
0
3.81
2021-05
0
4.04
2021-06
0
4.97
2021-07
0
4.05
2021-08
0
4.71
2021-09
0
3.73
2021-10
0
2.98
2021-11
0
3.98
2021-12
0
3.68
2022-01
0
3.2
2022-02
0
3.25
2022-03
0
3.47
2022-04
0
3.19
2022-05
0
3.03
2022-06
0
4.09
2022-07
0
3.53
2022-08
0
4.16
2022-09
0
3.76
2022-10
0
3.7
2022-11
0
4.21
2022-12
0
4.34
2023-01
0
3.37
2023-02
0
3.86
2023-03
0
4.18
2023-04
0
3.81
2023-05
0
4.84
2023-06
0
3.98
2023-07
0
3.87
2023-08
0
3.56
2023-09
0
3.83
2023-10
0
3.13
2023-11
0
3.78
2023-12
0
3.24
2024-01
0
3.67
2024-02
0
4.14
2024-03
0
4.01
2024-04
0
3.58
2024-05
0
3.03
2024-06
0
3.41
2024-07
0
3.1
2024-08
0
3.22
2024-09
0
4.4
2024-10
0
3.32
2024-11
0
3.09
2024-12
0
3.55
2025-01
0
2.89
2025-02
0
6.13
2025-03
0
4.71
2025-04
0
2.38
2025-05
0
3.4
2025-06
0
3.12
2025-07
0
3.28
2025-08
0
2.92
2025-09
0
2.71
2025-10
0
3.33
2025-11
0
3.15
2025-12
0
3.15
2026-01
0
2.3
2026-02
0
2.97
2026-03
0
4
2026-04
0
4.58
2026-05
0
4.46
2026-06
0
11.35
This device (reports/month)Average device in ERL, HBC, HBE (reports/device/month)