RobotRisk › Stryker Mako › 15 Apr 2024
Class II recall of Mako 3.0/3.1 software over error #3 causing loss of robotic function mid-surgery
S3 · 15 Apr 2024 · Stryker Mako
Record
| Company | Stryker Mako |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 15 Apr 2024 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (recall, enforcement, or fleet-wide fault) |
| Scale | Mako 3.0 and 3.1 software, field correction to installed base |
| Confidence | medium |
| Verified flag | Cited source on file; not independently re-verified |
Summary
Stryker issued an urgent field safety notice and FDA Class II recall for Mako total knee/hip application software after an increase in software error #3 codes occurring when the system was not shut down/restarted between switching total knee and total hip applications, which could cause loss or deterioration of robotic system function and extended surgery time.
Primary source
Publisher: MassDevice · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 15 Apr 2024 | Class II recall of Mako 3.0/3.1 software over error #3 causing loss of robotic function mid-surgery | MassDevice | MassDevice |
Stryker Mako other incidents timeline
Medical robotics context
recall context
Stryker Mako industry position
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Other Stryker Mako entries
- 08 Aug 2022 - Class II recall of Mako USB converter / Polaris Spectra camera tracking hardware
- ~Jul 2018 - Stryker Mako Restoris MCK knee implant lawsuit removed to federal court (Perry v. Stryker/Mako)
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