S4 · 09/2026 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | regulatory |
| Date | 09/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S4 (serious injury, total loss, or grounding) |
| Scale | 454 reports |
| Confidence | high |
| Verification | Cited source on file; not independently re-verified |
| Source | openFDA MAUDE |
openFDA MAUDE adverse-event reports since 2020 for the Mako platform: 0 death, 132 injury, 322 malfunction reports. Aggregate regulatory record; MAUDE reports are unverified submissions and include user error.
This is an aggregate regulatory record summarizing a regulator database, not a single event; it is refreshed from the source on every update cycle.