Mako Surgical Corp.
FDA adverse event reports naming Mako Surgical Corp. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MAKO SURGICAL CORP..
- Total reports
- 5,581
- Deaths
- 0
- Injuries
- 1,208
- Malfunctions
- 4,369
Reports per year
912
1813
6014
29815
47216
67217
80518
92719
39720
22121
18822
19123
30324
63825
31126
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Orthopedic Stereotaxic InstrumentOLO4,642
- Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerNPJ620
- Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOQG74
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH50
- Neurological Stereotaxic InstrumentHAW48
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX38
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY27
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH20
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH13
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI11
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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