Biolox Delta Modular Head 36mm SHORT -4.0mm 12/14 Eurocone Taper
Model 104.3600 · CORIN LTD · DI 05055196964372
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
UDILibrary device dossier · generated 2026-09-13 · 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 (13)
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: 13
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.38 |
| 2019-02 | 0 | 2.17 |
| 2019-03 | 0 | 2.44 |
| 2019-04 | 0 | 2.41 |
| 2019-05 | 0 | 1.91 |
| 2019-06 | 0 | 1.68 |
| 2019-07 | 0 | 1.62 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1.95 |
| 2019-10 | 0 | 2.18 |
| 2019-11 | 0 | 2.02 |
| 2019-12 | 0 | 2.22 |
| 2020-01 | 0 | 2.6 |
| 2020-02 | 0 | 2.2 |
| 2020-03 | 0 | 2.76 |
| 2020-04 | 0 | 2.1 |
| 2020-05 | 0 | 1.96 |
| 2020-06 | 0 | 1.9 |
| 2020-07 | 0 | 2.35 |
| 2020-08 | 0 | 1.97 |
| 2020-09 | 0 | 2.43 |
| 2020-10 | 0 | 2.38 |
| 2020-11 | 0 | 2.11 |
| 2020-12 | 0 | 2.16 |
| 2021-01 | 0 | 2.24 |
| 2021-02 | 0 | 1.96 |
| 2021-03 | 0 | 1.94 |
| 2021-04 | 0 | 1.96 |
| 2021-05 | 0 | 1.97 |
| 2021-06 | 0 | 2.23 |
| 2021-07 | 0 | 2.25 |
| 2021-08 | 0 | 2.21 |
| 2021-09 | 0 | 2.45 |
| 2021-10 | 0 | 2.19 |
| 2021-11 | 0 | 1.98 |
| 2021-12 | 0 | 2.12 |
| 2022-01 | 0 | 2.01 |
| 2022-02 | 0 | 2.06 |
| 2022-03 | 0 | 2.07 |
| 2022-04 | 0 | 2.05 |
| 2022-05 | 0 | 2.19 |
| 2022-06 | 0 | 2.09 |
| 2022-07 | 0 | 2.05 |
| 2022-08 | 0 | 2.11 |
| 2022-09 | 0 | 2.2 |
| 2022-10 | 0 | 2.13 |
| 2022-11 | 0 | 2.22 |
| 2022-12 | 0 | 2.07 |
| 2023-01 | 1 | 2.26 |
| 2023-02 | 0 | 2.08 |
| 2023-03 | 0 | 2.19 |
| 2023-04 | 0 | 2.24 |
| 2023-05 | 2 | 2.13 |
| 2023-06 | 0 | 2.26 |
| 2023-07 | 0 | 2.16 |
| 2023-08 | 1 | 1.92 |
| 2023-09 | 0 | 1.97 |
| 2023-10 | 0 | 1.67 |
| 2023-11 | 0 | 1.64 |
| 2023-12 | 0 | 1.74 |
| 2024-01 | 1 | 1.72 |
| 2024-02 | 1 | 2.06 |
| 2024-03 | 1 | 1.97 |
| 2024-04 | 0 | 1.82 |
| 2024-05 | 0 | 2.22 |
| 2024-06 | 0 | 1.97 |
| 2024-07 | 0 | 1.71 |
| 2024-08 | 0 | 2.03 |
| 2024-09 | 0 | 1.97 |
| 2024-10 | 0 | 1.81 |
| 2024-11 | 0 | 1.79 |
| 2024-12 | 0 | 1.62 |
| 2025-01 | 0 | 1.99 |
| 2025-02 | 1 | 1.58 |
| 2025-03 | 0 | 1.8 |
| 2025-04 | 1 | 1.84 |
| 2025-05 | 0 | 1.78 |
| 2025-06 | 2 | 1.87 |
| 2025-07 | 0 | 1.81 |
| 2025-08 | 2 | 1.78 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1.72 |
| 2025-11 | 0 | 1.8 |
| 2025-12 | 0 | 1.92 |
| 2026-01 | 0 | 1.92 |
| 2026-02 | 0 | 1.72 |
| 2026-03 | 0 | 1.95 |
| 2026-04 | 0 | 1.97 |
| 2026-05 | 0 | 1.76 |
| 2026-06 | 0 | 1.8 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K110087 — cites (transitively): K100412 (d1), K071535 (d2), K082844 (d2), K083762 (d2) — cited as predicate by K111481, K111911, K130128, K142761, K152893, K153725, K170359, K172551, K172857, K180973, K182321, K183532, K190834, K192656, K201657, K241472
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CORIN LTD
Nothing in the loaded window.