Unnamed device
Model 40R2500 · MEDTRONIC XOMED, INC. · DI 00763000033798
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 (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2021-08-31 | Z-0158-2022 | Class II | Open, Classified | There was an increase in complaints related to tip breaks and wobble/vibration. | code info di |
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.29 |
| 2019-02 | 0 | 3.68 |
| 2019-03 | 0 | 4.9 |
| 2019-04 | 0 | 3.39 |
| 2019-05 | 0 | 4 |
| 2019-06 | 0 | 3.65 |
| 2019-07 | 0 | 3.23 |
| 2019-08 | 0 | 3.89 |
| 2019-09 | 0 | 2.94 |
| 2019-10 | 0 | 3 |
| 2019-11 | 0 | 3.32 |
| 2019-12 | 0 | 3.76 |
| 2020-01 | 0 | 3.19 |
| 2020-02 | 0 | 6.36 |
| 2020-03 | 0 | 5.11 |
| 2020-04 | 0 | 3.12 |
| 2020-05 | 0 | 2.9 |
| 2020-06 | 0 | 4.24 |
| 2020-07 | 0 | 3.8 |
| 2020-08 | 0 | 3.06 |
| 2020-09 | 0 | 4.6 |
| 2020-10 | 0 | 3.78 |
| 2020-11 | 0 | 4.29 |
| 2020-12 | 0 | 4.34 |
| 2021-01 | 0 | 3.3 |
| 2021-02 | 0 | 3.03 |
| 2021-03 | 0 | 3.51 |
| 2021-04 | 0 | 2.92 |
| 2021-05 | 0 | 2.73 |
| 2021-06 | 0 | 3.62 |
| 2021-07 | 0 | 3.29 |
| 2021-08 | 0 | 4.9 |
| 2021-09 | 0 | 3.59 |
| 2021-10 | 0 | 2.88 |
| 2021-11 | 0 | 3.54 |
| 2021-12 | 0 | 4.3 |
| 2022-01 | 0 | 2.93 |
| 2022-02 | 0 | 3.79 |
| 2022-03 | 0 | 3.94 |
| 2022-04 | 0 | 2.55 |
| 2022-05 | 0 | 3.36 |
| 2022-06 | 0 | 3.9 |
| 2022-07 | 0 | 3.02 |
| 2022-08 | 0 | 3.9 |
| 2022-09 | 0 | 4.04 |
| 2022-10 | 0 | 3.41 |
| 2022-11 | 0 | 3.62 |
| 2022-12 | 0 | 4.61 |
| 2023-01 | 0 | 3.21 |
| 2023-02 | 0 | 3.83 |
| 2023-03 | 0 | 3.93 |
| 2023-04 | 0 | 3.25 |
| 2023-05 | 0 | 4.68 |
| 2023-06 | 0 | 4.04 |
| 2023-07 | 0 | 2.9 |
| 2023-08 | 0 | 3.5 |
| 2023-09 | 0 | 3.58 |
| 2023-10 | 0 | 2.62 |
| 2023-11 | 0 | 4.11 |
| 2023-12 | 0 | 2.85 |
| 2024-01 | 0 | 3.18 |
| 2024-02 | 0 | 3.13 |
| 2024-03 | 0 | 3.59 |
| 2024-04 | 0 | 2.68 |
| 2024-05 | 0 | 2.7 |
| 2024-06 | 0 | 3.29 |
| 2024-07 | 0 | 2.6 |
| 2024-08 | 0 | 2.75 |
| 2024-09 | 0 | 3.49 |
| 2024-10 | 0 | 2.67 |
| 2024-11 | 0 | 2.16 |
| 2024-12 | 0 | 3.35 |
| 2025-01 | 0 | 2.56 |
| 2025-02 | 0 | 3.52 |
| 2025-03 | 0 | 2.34 |
| 2025-04 | 0 | 1.85 |
| 2025-05 | 0 | 2.19 |
| 2025-06 | 0 | 2.48 |
| 2025-07 | 0 | 2.47 |
| 2025-08 | 0 | 1.85 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 2.75 |
| 2025-11 | 0 | 3.08 |
| 2025-12 | 0 | 2.91 |
| 2026-01 | 0 | 2.01 |
| 2026-02 | 0 | 2.5 |
| 2026-03 | 0 | 4.3 |
| 2026-04 | 0 | 4.4 |
| 2026-05 | 0 | 4.84 |
| 2026-06 | 0 | 15.24 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K081475 — cited as predicate by K111520, K121264, K130755, K132264, K133061, K141122, K143399, K160713, K163565, K170312, K193630, K233958, K240568
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC XOMED, INC.
- VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
- VAI 2021-10-29 Medtronic Xomed, Inc. · 5 citations
- VAI 2015-09-21 Medtronic Xomed, Inc. · 1 citations
- VAI 2012-07-03 Medtronic Xomed, Inc. · 8 citations
- NAI 2012-06-06 Medtronic Xomed, Inc. · 0 citations
- VAI 2010-08-05 Medtronic Xomed, Inc. · 4 citations