Home › MIZUHO ORTHOPEDIC SYSTEMS, INC. › Coupler II Main Assembly
Coupler II Main Assembly
MIZUHO ORTHOPEDIC SYSTEMS, INC. · Model 5873 · UDI-DI 00842430104534
10
510(k) clearances
632
Adverse events (3 deaths)
41
Recalls
24
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 | Baxter Healthcare Corporation | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 | Baxter Healthcare Corporation | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.