Print-ready dossier — use your browser's print dialog to save as PDF.
iBur
Stryker Instruments
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 (19)
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.
Malfunction: 18 · Injury: 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-09 | 3 | — |
| 2023-03 | 2 | — |
| 2023-04 | 1 | — |
| 2023-06 | 2 | — |
| 2023-07 | 4 | — |
| 2023-09 | 1 | — |
| 2023-10 | 1 | — |
| 2024-01 | 1 | — |
| 2024-02 | 1 | — |
| 2024-05 | 1 | — |
| 2024-08 | 1 | — |
| 2026-01 | 1 | — |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Stryker Instruments
- NAI 2011-01-05 Stryker Instruments · 0 citations