RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk / medical robotics / Stryker Mako

Stryker Mako

Products: Ortho robot. Risk band: High   RobotRisk index 65.3/100 (incidents/exposure, time-weighted) · 99th percentile of 162 medical robotics companies.

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 index of 65.6 and 99.4th percentile place the company at the top of the medical-robotics category, the highest standing among the medical-robotics entities in this set. The record is dominated by manufacturer-initiated Class II corrections rather than fatalities or regulator-driven warning actions.

Entries by year and severity

012018 S2: 11182022 S2: 11222024 S3: 11242026 S4: 1126
S1S2S3S4S5

By incident type

By severity

RobotRisk index vs medical robotics alternatives

Comparisons over time

RobotRisk index over time

Yearly entries vs category average

recall over time vs category

Incident log (3 unique incidents)

SevDateTypeLocationIncidentSource
S409/2026 regulatory FDA MAUDE record 2020-2026: 0 death, 132 injury, 322 malfunction reports · 454 reports openFDA MAUDE
S304/15
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 corre… MassDevice
S208/08
2022
recall Class II recall of Mako USB converter / Polaris Spectra camera tracking hardware · Mako tracking hardware components FDA
S207/2018 recall Stryker Mako Restoris MCK knee implant lawsuit removed to federal court (Perry v. Stryker/Mako) · individual implant failure, part of br… AboutLawsuits.com
132 individual reports under the MAUDE regulator record (supporting filings, not counted as incidents)
SevDateTypeReportSource
S308/2026 injury MAUDE injury report 3005985723-2026-00400 (Mako) · MDR 3005985723-2026-00400 openFDA MAUDE
S308/2026 injury MAUDE injury report 3005985723-2026-00412 (Mako) · MDR 3005985723-2026-00412 openFDA MAUDE
S307/2026 injury MAUDE injury report 3005985723-2026-00336 (Mako) · MDR 3005985723-2026-00336 openFDA MAUDE
S307/2026 injury MAUDE injury report 3005985723-2026-00337 (Mako) · MDR 3005985723-2026-00337 openFDA MAUDE
S307/2026 injury MAUDE injury report 3005985723-2026-00354 (Mako) · MDR 3005985723-2026-00354 openFDA MAUDE
S307/2026 injury MAUDE injury report 3005985723-2026-00356 (Mako) · MDR 3005985723-2026-00356 openFDA MAUDE
S306/2026 injury MAUDE injury report 3005985723-2026-00301 (Mako) · MDR 3005985723-2026-00301 openFDA MAUDE
S305/2026 injury MAUDE injury report 3005985723-2026-00215 (Mako) · MDR 3005985723-2026-00215 openFDA MAUDE
S305/2026 injury MAUDE injury report 3005985723-2026-00231 (Mako) · MDR 3005985723-2026-00231 openFDA MAUDE
S304/2026 injury MAUDE injury report 3005985723-2026-00174 (Mako) · MDR 3005985723-2026-00174 openFDA MAUDE
S304/2026 injury MAUDE injury report 3005985723-2026-00175 (Mako) · MDR 3005985723-2026-00175 openFDA MAUDE
S303/2026 injury MAUDE injury report 3005985723-2026-00121 (Mako) · MDR 3005985723-2026-00121 openFDA MAUDE
S302/2026 injury MAUDE injury report 3005985723-2026-00053 (Mako) · MDR 3005985723-2026-00053 openFDA MAUDE
S302/2026 injury MAUDE injury report 3005985723-2026-00096 (Mako) · MDR 3005985723-2026-00096 openFDA MAUDE
S302/2026 injury MAUDE injury report 3005985723-2026-00098 (Mako) · MDR 3005985723-2026-00098 openFDA MAUDE
S312/2025 injury MAUDE injury report 3005985723-2025-00564 (Mako) · MDR 3005985723-2025-00564 openFDA MAUDE
S312/2025 injury MAUDE injury report MW5180790 (Mako) · MDR MW5180790 openFDA MAUDE
S311/2025 injury MAUDE injury report 3005985723-2025-00499 (Mako) · MDR 3005985723-2025-00499 openFDA MAUDE
S311/2025 injury MAUDE injury report 3005985723-2025-00505 (Mako) · MDR 3005985723-2025-00505 openFDA MAUDE
S311/2025 injury MAUDE injury report 3005985723-2025-00516 (Mako) · MDR 3005985723-2025-00516 openFDA MAUDE
S311/2025 injury MAUDE injury report 3005985723-2025-00518 (Mako) · MDR 3005985723-2025-00518 openFDA MAUDE
S311/2025 injury MAUDE injury report 3005985723-2025-00556 (Mako) · MDR 3005985723-2025-00556 openFDA MAUDE
S310/2025 injury MAUDE injury report 3005985723-2025-00496 (Mako) · MDR 3005985723-2025-00496 openFDA MAUDE
S309/2025 injury MAUDE injury report 3005985723-2025-00407 (Mako) · MDR 3005985723-2025-00407 openFDA MAUDE
S308/2025 injury MAUDE injury report 3005985723-2025-00377 (Mako) · MDR 3005985723-2025-00377 openFDA MAUDE
S308/2025 injury MAUDE injury report 3005985723-2025-00394 (Mako) · MDR 3005985723-2025-00394 openFDA MAUDE
S307/2025 injury MAUDE injury report 3005985723-2025-00316 (Mako) · MDR 3005985723-2025-00316 openFDA MAUDE
S307/2025 injury MAUDE injury report 3005985723-2025-00353 (Mako) · MDR 3005985723-2025-00353 openFDA MAUDE
S306/2025 injury MAUDE injury report 3005985723-2025-00249 (Mako) · MDR 3005985723-2025-00249 openFDA MAUDE
S306/2025 injury MAUDE injury report 3005985723-2025-00276 (Mako) · MDR 3005985723-2025-00276 openFDA MAUDE
S306/2025 injury MAUDE injury report 3005985723-2025-00288 (Mako) · MDR 3005985723-2025-00288 openFDA MAUDE
S306/2025 injury MAUDE injury report 3005985723-2025-00291 (Mako) · MDR 3005985723-2025-00291 openFDA MAUDE
S306/2025 injury MAUDE injury report 3005985723-2025-00293 (Mako) · MDR 3005985723-2025-00293 openFDA MAUDE
S305/2025 injury MAUDE injury report 3005985723-2025-00195 (Mako) · MDR 3005985723-2025-00195 openFDA MAUDE
S305/2025 injury MAUDE injury report 3005985723-2025-00194 (Mako) · MDR 3005985723-2025-00194 openFDA MAUDE
S305/2025 injury MAUDE injury report 3005985723-2025-00220 (Mako) · MDR 3005985723-2025-00220 openFDA MAUDE
S305/2025 injury MAUDE injury report 3005985723-2025-00242 (Mako) · MDR 3005985723-2025-00242 openFDA MAUDE
S304/2025 injury MAUDE injury report 3005985723-2025-00130 (Mako) · MDR 3005985723-2025-00130 openFDA MAUDE
S302/2025 injury MAUDE injury report 3005985723-2025-00060 (Mako) · MDR 3005985723-2025-00060 openFDA MAUDE
S302/2025 injury MAUDE injury report 3005985723-2025-00067 (Mako) · MDR 3005985723-2025-00067 openFDA MAUDE
S302/2025 injury MAUDE injury report 0002249697-2025-00245 (Mako) · MDR 0002249697-2025-00245 openFDA MAUDE
S301/2025 injury MAUDE injury report 3005985723-2025-00004 (Mako) · MDR 3005985723-2025-00004 openFDA MAUDE
S312/2024 injury MAUDE injury report 3005985723-2024-00264 (Mako) · MDR 3005985723-2024-00264 openFDA MAUDE
S312/2024 injury MAUDE injury report 3005985723-2024-00271 (Mako) · MDR 3005985723-2024-00271 openFDA MAUDE
S310/2024 injury MAUDE injury report 3005985723-2024-00212 (Mako) · MDR 3005985723-2024-00212 openFDA MAUDE
S310/2024 injury MAUDE injury report 3005985723-2024-00218 (Mako) · MDR 3005985723-2024-00218 openFDA MAUDE
S308/2024 injury MAUDE injury report 3005985723-2024-00122 (Mako) · MDR 3005985723-2024-00122 openFDA MAUDE
S308/2024 injury MAUDE injury report 3005985723-2024-00138 (Mako) · MDR 3005985723-2024-00138 openFDA MAUDE
S307/2024 injury MAUDE injury report 3005985723-2024-00092 (Mako) · MDR 3005985723-2024-00092 openFDA MAUDE
S305/2024 injury MAUDE injury report 3005985723-2024-00067 (Mako) · MDR 3005985723-2024-00067 openFDA MAUDE
S304/2024 injury MAUDE injury report 3005985723-2024-00044 (Mako) · MDR 3005985723-2024-00044 openFDA MAUDE
S304/2024 injury MAUDE injury report MW5154366 (Mako) · MDR MW5154366 openFDA MAUDE
S303/2024 injury MAUDE injury report 3005985723-2024-00039 (Mako) · MDR 3005985723-2024-00039 openFDA MAUDE
S302/2024 injury MAUDE injury report 3005985723-2024-00020 (Mako) · MDR 3005985723-2024-00020 openFDA MAUDE
S302/2024 injury MAUDE injury report 3005985723-2024-00026 (Mako) · MDR 3005985723-2024-00026 openFDA MAUDE
S301/2024 injury MAUDE injury report MW5149922 (Mako) · MDR MW5149922 openFDA MAUDE
S311/2023 injury MAUDE injury report 3005985723-2023-00167 (Mako) · MDR 3005985723-2023-00167 openFDA MAUDE
S311/2023 injury MAUDE injury report 3005985723-2023-00173 (Mako) · MDR 3005985723-2023-00173 openFDA MAUDE
S310/2023 injury MAUDE injury report 0002249697-2023-01171 (Mako) · MDR 0002249697-2023-01171 openFDA MAUDE
S310/2023 injury MAUDE injury report 3005985723-2023-00158 (Mako) · MDR 3005985723-2023-00158 openFDA MAUDE
S309/2023 injury MAUDE injury report 3005985723-2023-00131 (Mako) · MDR 3005985723-2023-00131 openFDA MAUDE
S309/2023 injury MAUDE injury report 3005985723-2023-00132 (Mako) · MDR 3005985723-2023-00132 openFDA MAUDE
S308/2023 injury MAUDE injury report 3005985723-2023-00123 (Mako) · MDR 3005985723-2023-00123 openFDA MAUDE
S308/2023 injury MAUDE injury report MW5120510 (Mako) · MDR MW5120510 openFDA MAUDE
S308/2023 injury MAUDE injury report MW5120511 (Mako) · MDR MW5120511 openFDA MAUDE
S308/2023 injury MAUDE injury report MW5120512 (Mako) · MDR MW5120512 openFDA MAUDE
S307/2023 injury MAUDE injury report 3005985723-2023-00118 (Mako) · MDR 3005985723-2023-00118 openFDA MAUDE
S307/2023 injury MAUDE injury report 3005985723-2023-00119 (Mako) · MDR 3005985723-2023-00119 openFDA MAUDE
S306/2023 injury MAUDE injury report 3005985723-2023-00103 (Mako) · MDR 3005985723-2023-00103 openFDA MAUDE
S305/2023 injury MAUDE injury report 3005985723-2023-00078 (Mako) · MDR 3005985723-2023-00078 openFDA MAUDE
S305/2023 injury MAUDE injury report 3005985723-2023-00081 (Mako) · MDR 3005985723-2023-00081 openFDA MAUDE
S304/2023 injury MAUDE injury report 3005985723-2023-00071 (Mako) · MDR 3005985723-2023-00071 openFDA MAUDE
S310/2022 injury MAUDE injury report 3005985723-2022-00129 (Mako) · MDR 3005985723-2022-00129 openFDA MAUDE
S308/2022 injury MAUDE injury report 3005985723-2022-00101 (Mako) · MDR 3005985723-2022-00101 openFDA MAUDE
S308/2022 injury MAUDE injury report 3005985723-2022-00105 (Mako) · MDR 3005985723-2022-00105 openFDA MAUDE
S306/2022 injury MAUDE injury report 3005985723-2022-00080 (Mako) · MDR 3005985723-2022-00080 openFDA MAUDE
S306/2022 injury MAUDE injury report 3005985723-2022-00087 (Mako) · MDR 3005985723-2022-00087 openFDA MAUDE
S305/2022 injury MAUDE injury report 3005985723-2022-00058 (Mako) · MDR 3005985723-2022-00058 openFDA MAUDE
S304/2022 injury MAUDE injury report MW5108838 (Mako) · MDR MW5108838 openFDA MAUDE
S303/2022 injury MAUDE injury report 0002249697-2022-00430 (Mako) · MDR 0002249697-2022-00430 openFDA MAUDE
S303/2022 injury MAUDE injury report 3005985723-2022-00035 (Mako) · MDR 3005985723-2022-00035 openFDA MAUDE
S302/2022 injury MAUDE injury report 3005985723-2022-00012 (Mako) · MDR 3005985723-2022-00012 openFDA MAUDE
S302/2022 injury MAUDE injury report 3005985723-2022-00021 (Mako) · MDR 3005985723-2022-00021 openFDA MAUDE
S301/2022 injury MAUDE injury report 0002249697-2022-00054 (Mako) · MDR 0002249697-2022-00054 openFDA MAUDE
S311/2021 injury MAUDE injury report 3005985723-2021-00180 (Mako) · MDR 3005985723-2021-00180 openFDA MAUDE
S311/2021 injury MAUDE injury report 3005985723-2021-00196 (Mako) · MDR 3005985723-2021-00196 openFDA MAUDE
S311/2021 injury MAUDE injury report 3005985723-2021-00204 (Mako) · MDR 3005985723-2021-00204 openFDA MAUDE
S310/2021 injury MAUDE injury report 3005985723-2021-00165 (Mako) · MDR 3005985723-2021-00165 openFDA MAUDE
S310/2021 injury MAUDE injury report 3005985723-2021-00166 (Mako) · MDR 3005985723-2021-00166 openFDA MAUDE
S310/2021 injury MAUDE injury report 3005985723-2021-00170 (Mako) · MDR 3005985723-2021-00170 openFDA MAUDE
S310/2021 injury MAUDE injury report 3005985723-2021-00174 (Mako) · MDR 3005985723-2021-00174 openFDA MAUDE
S310/2021 injury MAUDE injury report 3005985723-2021-00175 (Mako) · MDR 3005985723-2021-00175 openFDA MAUDE
S308/2021 injury MAUDE injury report 3005985723-2021-00145 (Mako) · MDR 3005985723-2021-00145 openFDA MAUDE
S307/2021 injury MAUDE injury report 3005985723-2021-00132 (Mako) · MDR 3005985723-2021-00132 openFDA MAUDE
S307/2021 injury MAUDE injury report 0002249697-2021-01295 (Mako) · MDR 0002249697-2021-01295 openFDA MAUDE
S306/2021 injury MAUDE injury report 3005985723-2021-00107 (Mako) · MDR 3005985723-2021-00107 openFDA MAUDE
S306/2021 injury MAUDE injury report 3005985723-2021-00113 (Mako) · MDR 3005985723-2021-00113 openFDA MAUDE
S305/2021 injury MAUDE injury report 0002249697-2021-00872 (Mako) · MDR 0002249697-2021-00872 openFDA MAUDE
S305/2021 injury MAUDE injury report 3005985723-2021-00092 (Mako) · MDR 3005985723-2021-00092 openFDA MAUDE
S304/2021 injury MAUDE injury report 3005985723-2021-00067 (Mako) · MDR 3005985723-2021-00067 openFDA MAUDE
S304/2021 injury MAUDE injury report 3005985723-2021-00072 (Mako) · MDR 3005985723-2021-00072 openFDA MAUDE
S303/2021 injury MAUDE injury report 0002249697-2021-00505 (Mako) · MDR 0002249697-2021-00505 openFDA MAUDE
S303/2021 injury MAUDE injury report 3005985723-2021-00053 (Mako) · MDR 3005985723-2021-00053 openFDA MAUDE
S302/2021 injury MAUDE injury report 3005985723-2021-00017 (Mako) · MDR 3005985723-2021-00017 openFDA MAUDE
S302/2021 injury MAUDE injury report 3005985723-2021-00018 (Mako) · MDR 3005985723-2021-00018 openFDA MAUDE
S302/2021 injury MAUDE injury report 3005985723-2021-00021 (Mako) · MDR 3005985723-2021-00021 openFDA MAUDE
S302/2021 injury MAUDE injury report 3005985723-2021-00022 (Mako) · MDR 3005985723-2021-00022 openFDA MAUDE
S301/2021 injury MAUDE injury report 3005985723-2021-00005 (Mako) · MDR 3005985723-2021-00005 openFDA MAUDE
S301/2021 injury MAUDE injury report 3005985723-2021-00006 (Mako) · MDR 3005985723-2021-00006 openFDA MAUDE
S301/2021 injury MAUDE injury report 3005985723-2021-00007 (Mako) · MDR 3005985723-2021-00007 openFDA MAUDE
S301/2021 injury MAUDE injury report 0002249697-2021-00064 (Mako) · MDR 0002249697-2021-00064 openFDA MAUDE
S301/2021 injury MAUDE injury report 3005985723-2021-00009 (Mako) · MDR 3005985723-2021-00009 openFDA MAUDE
S301/2021 injury MAUDE injury report 3005985723-2021-00012 (Mako) · MDR 3005985723-2021-00012 openFDA MAUDE
S311/2020 injury MAUDE injury report 3005985723-2020-00345 (Mako) · MDR 3005985723-2020-00345 openFDA MAUDE
S311/2020 injury MAUDE injury report 3005985723-2020-00354 (Mako) · MDR 3005985723-2020-00354 openFDA MAUDE
S311/2020 injury MAUDE injury report 3005985723-2020-00357 (Mako) · MDR 3005985723-2020-00357 openFDA MAUDE
S311/2020 injury MAUDE injury report MW5097864 (Mako) · MDR MW5097864 openFDA MAUDE
S310/2020 injury MAUDE injury report 0002249697-2020-02106 (Mako) · MDR 0002249697-2020-02106 openFDA MAUDE
S310/2020 injury MAUDE injury report 3005985723-2020-00328 (Mako) · MDR 3005985723-2020-00328 openFDA MAUDE
S310/2020 injury MAUDE injury report 3005985723-2020-00330 (Mako) · MDR 3005985723-2020-00330 openFDA MAUDE
S310/2020 injury MAUDE injury report 3005985723-2020-00332 (Mako) · MDR 3005985723-2020-00332 openFDA MAUDE
S309/2020 injury MAUDE injury report 3005985723-2020-00292 (Mako) · MDR 3005985723-2020-00292 openFDA MAUDE
S308/2020 injury MAUDE injury report 3005985723-2020-00246 (Mako) · MDR 3005985723-2020-00246 openFDA MAUDE
S308/2020 injury MAUDE injury report 0002249697-2020-01649 (Mako) · MDR 0002249697-2020-01649 openFDA MAUDE
S308/2020 injury MAUDE injury report 3005985723-2020-00287 (Mako) · MDR 3005985723-2020-00287 openFDA MAUDE
S306/2020 injury MAUDE injury report 3005985723-2020-00223 (Mako) · MDR 3005985723-2020-00223 openFDA MAUDE
S303/2020 injury MAUDE injury report 3005985723-2020-00149 (Mako) · MDR 3005985723-2020-00149 openFDA MAUDE
S303/2020 injury MAUDE injury report 3005985723-2020-00151 (Mako) · MDR 3005985723-2020-00151 openFDA MAUDE
S301/2020 injury MAUDE injury report 0002249697-2020-00140 (Mako) · MDR 0002249697-2020-00140 openFDA MAUDE
S301/2020 injury MAUDE injury report 0002249697-2020-00141 (Mako) · MDR 0002249697-2020-00141 openFDA MAUDE
S301/2020 injury MAUDE injury report 0002249697-2020-00142 (Mako) · MDR 0002249697-2020-00142 openFDA MAUDE
S301/2020 injury MAUDE injury report MW5092377 (Mako) · MDR MW5092377 openFDA MAUDE

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