RobotRisk › Medical robotics › Stryker Mako

Stryker Mako

Robot types: Ortho robot. Risk band: Elevated RobotRisk index 24.6/100 (severity- and time-weighted incidents) · ranked 10 of 25 among Medical robotics companies with incidents (274 tracked).

Analyst brief

The record contains three entries spanning 2018 to 2024, all recalls, with severity ranging from 2 to 3: a 2024 Class II software recall for an error causing loss of robotic function, a 2022 Class II recall of tracking hardware, and a 2018 implant-related lawsuit. The entries recur across both software and hardware subsystems of the same robotic platform over a six-year span, indicating a repeated pattern rather than a single incident. The record is dominated by manufacturer-initiated Class II corrections rather than fatalities or regulator-driven warning actions.

Risk index

24.6/100RobotRisk index

21.8/100Median index across the 25 Medical robotics companies with incident history (274 tracked, 249 with none)

10 of 25Rank in Medical robotics (of 25 with incident history)

ElevatedRisk band

Products and robot types

Industries: Medical robotics · Sectors: Hospitals and Health Care

Risk is scored per product and robot type: each incident is attributed to the product it names, or to the company's matching robot type.

Robot type	Share of company risk	Rank within type
Ortho robot	100%	2 of 3

Product	Robot type	Status	Incidents	Index
Mako	Ortho robot	ga	3	24.6

Incident timeline

Comparisons over time

Per-type breakdown

Incident type	Unique incidents	Share
recall	3	100%

Unique incident list

3 unique incidents on file for this company.

Sev	Date	Type	Location	Incident	Source
S3	15 Apr 2024	recall	—	Class II recall of Mako 3.0/3.1 software over error #3 causing loss of robotic function mid-surgery · Mako 3.0 and 3.1 software, field correction to installed base	MassDevice
S2	08 Aug 2022	recall	—	Class II recall of Mako USB converter / Polaris Spectra camera tracking hardware · Mako tracking hardware components	FDA
S2	~Jul 2018	recall	—	Stryker Mako Restoris MCK knee implant lawsuit removed to federal court (Perry v. Stryker/Mako) · individual implant failure, part of broader MCK litigation	AboutLawsuits.com