ORTHOFIX MODULSYSTEM
Model 1 · ORTHOFIX SRL · DI 18032568866636
JDW — Pin, Fixation, Threaded · Class II · 21 CFR 888.3040
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 (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2026-06-10 | Z-2729-2026 | Class II | Open, Classified | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | code info di |
Adverse-event reports — MAUDE (5)
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: 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.83 |
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 2 |
| 2019-06 | 0 | 1.33 |
| 2019-07 | 0 | 1.25 |
| 2019-08 | 0 | 17 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 2.67 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 5 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 1.8 |
| 2020-05 | 0 | 2.5 |
| 2020-06 | 0 | 2.33 |
| 2020-07 | 0 | 1.33 |
| 2020-08 | 0 | 1.5 |
| 2020-10 | 1 | 1.33 |
| 2020-11 | 0 | 2.83 |
| 2020-12 | 0 | 2.5 |
| 2021-01 | 0 | 1.5 |
| 2021-02 | 0 | 3.33 |
| 2021-03 | 0 | 6 |
| 2021-04 | 0 | 2.11 |
| 2021-05 | 0 | 12.29 |
| 2021-06 | 0 | 2.83 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 1.25 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 1.5 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 2.67 |
| 2022-03 | 0 | 1.75 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 1.33 |
| 2022-06 | 0 | 3 |
| 2022-07 | 0 | 2.5 |
| 2022-08 | 0 | 1.5 |
| 2022-09 | 0 | 1.67 |
| 2022-10 | 0 | 1.75 |
| 2022-11 | 0 | 3 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 1.33 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1.2 |
| 2023-04 | 0 | 1.33 |
| 2023-05 | 0 | 1.5 |
| 2023-06 | 0 | 1 |
| 2023-07 | 0 | 1.2 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 3 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 1.4 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1.6 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2024-11 | 0 | 1.5 |
| 2024-12 | 0 | 2 |
| 2025-01 | 0 | 2 |
| 2025-02 | 4 | 2.83 |
| 2025-06 | 0 | 1.33 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 1.5 |
| 2025-12 | 0 | 1.25 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 1.4 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 1.5 |
| 2026-06 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K955848 — cited as predicate by K113770, K132820, K141078, K141760, K152242, K192181, K200518, K212044, K232648, K233867, K240049, K242861
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ORTHOFIX SRL
- VAI 2023-03-17 Orthofix U.S. LLC · 2 citations
- VAI 2012-09-27 Orthofix Srl · 1 citations
- VAI 2012-09-27 Orthofix Srl · 1 citations
- VAI 2011-06-24 Orthofix U.S. LLC · 1 citations
- NAI 2010-02-23 Orthofix U.S. LLC · 0 citations