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
- 5,627
- Deaths
- 0
- Injuries
- 1,213
- Malfunctions
- 4,410
Reports per year
912
1813
6014
29815
47216
67217
80518
92719
39720
22121
18822
19123
30324
63825
35726
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Orthopedic Stereotaxic InstrumentOLO4,687
- 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/PolymerHRY28
- 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.
Monitor Mako Surgical Corp. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.