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U.S. Department of Health and Human Services

Class 2 Device Recall The RIO (TGS 2.),

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 Class 2 Device Recall The RIO (TGS 2.), see related information
Date Posted November 19, 2012
Recall Status1 Terminated on May 22, 2013
Recall Number Z-0385-2013
Recall Event ID 63607
510(K)Number K081867 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000).
The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
Code Information ROB S/N GUD S/N CAM S/N
ROB036 GUD054 CAM054
ROB037 GUD043 CAM037
ROB038 GUD038 CAM038
ROB039 GUD039 CAM039
ROB040 GUD040 CAM035
ROB042 GUD042 CAM043
ROB046 GUD046 CAM046
ROB047 GUD044 CAM047
ROB048 GUD047 CAM048
ROB049 GUD048 CAM049
ROB051 GUD074 CAM074
ROB053 GUD053 CAM053
ROB054 GUD091 CAM091
ROB055 GUD055 CAM075
ROB056 GUD056 CAM066
ROB057 GUD058 CAM058
ROB059 GUD059 CAM059
ROB060 GUD060 CAM060
ROB061 GUD061 CAM061
ROB062 GUD063 CAM062
ROB063 GUD062 CAM063
ROB065 GUD065 CAM033
ROB066 GUD057 CAM057
ROB067 GUD067 CAM067
ROB069 GUD036 CAM036
ROB070 GUD070 CAM055
ROB071 GUD083 CAM083
ROB072 GUD072 CAM072
ROB074 GUD102 CAM102
ROB075 GUD103 CAM103
ROB076 GUD045 CAM045
ROB078 GUD082 CAM082
ROB079 GUD076 CAM076
ROB080 GUD071 CAM071
ROB081 GUD075 CAM070
ROB083 GUD069 CAM069
ROB084 GUD100 CAM100
ROB085 GUD079 CAM079
ROB086 GUD086 CAM086
ROB088 GUD088 CAM088
ROB089 GUD089 CAM089
ROB090 GUD080 CAM081
ROB091 GUD098 CAM098
ROB092 GUD051 CAM051
ROB093 GUD085 CAM085
ROB094 GUD094 CAM094
ROB095 GUD095 CAM095
ROB096 GUD125 CAM125
ROB097 GUD097 CAM097
ROB098 GUD093 CAM093
ROB099 GUD099 CAM099
ROB100 GUD081 CAM080
ROB101 GUD101 CAM101
ROB102 GUD077 CAM077
ROB103 GUD078 CAM078
ROB104 GUD104 CAM104
ROB106 GUD106 CAM106
ROB107 GUD107 CAM107
ROB108 GUD108 CAM108
ROB109 GUD109 CAM109
ROB110 GUD110 CAM110
ROB111 GUD111 CAM112
ROB112 GUD105 CAM111
ROB114 GUD113 CAM105
ROB116 GUD115 CAM116
ROB117 GUD116 CAM115
ROB118 GUD117 CAM117
ROB119 GUD118 CAM119
ROB120 GUD119 CAM118
ROB121 GUD120 CAM120
ROB122 GUD121 CAM121
ROB123 GUD122 CAM122
ROB124 GUD123 CAM123
ROB125 GUD124 CAM124
ROB126 GUD126 CAM126
ROB127 GUD127 CAM127
ROB129 GUD129 CAM129
ROB130 GUD130 CAM130
ROB131 GUD084 CAM084
ROB133 GUD133 CAM133
ROB134 GUD134 CAM134
ROB135 GUD135 CAM135
ROB136 GUD136 CAM136
ROB140 GUD140 CAM140
ROB141 GUD141 CAM141
ROB143 GUD143 CAM143
ROB145 GUD145 CAM145
ROB146 GUD146 CAM146
ROB147 GUD147 CAM147
ROB148 GUD148 CAM148
ROB149 GUD149 CAM149
ROB150 GUD150 CAM150
ROB151 GUD151 CAM151
ROB152 GUD152 CAM152
ROB153 GUD153 CAM153
ROB154 GUD154 CAM154
ROB155 GUD155 CAM155
ROB156 GUD156 CAM156
ROB158 GUD158 CAM158
ROB159 GUD159 CAM159
ROB160 GUD160 CAM160
ROB161 GUD161 CAM161
ROB163 GUD163 CAM163
ROB164 GUD164 CAM164
ROB165 GUD165 CAM165
ROB167 GUD167 CAM167
ROB170 GUD170 CAM170
ROB171 GUD131 CAM131
ROB172 GUD172 CAM172
ROB173 GUD173 CAM173
ROB175 GUD175 CAM175
ROB176 GUD176 CAM176
ROB177 GUD177 CAM177
ROB178 GUD178 CAM178
ROB180 GUD180 CAM180
ROB182 GUD182 CAM182
ROB183 GUD183 CAM183
ROB187 GUD187 CAM187
ROB191 GUD192 CAM191
ROB192 GUD193 CAM193
ROB193 GUD191 CAM192
ROB203 GUD203 CAM203
ROB204 GUD204 CAM204
ROB205 GUD205 CAM205
ROB206 GUD206 CAM206
ROB207 GUD207 CAM207
ROB050 GUD050 CAM050
ROB058 GUD066 CAM056
ROB073 GUD073 CAM073
ROB082 GUD037 CAM042
ROB137 GUD137 CAM137
ROB144 GUD144 CAM144
ROB168 GUD168 CAM168
ROB169 GUD169 CAM169
ROB181 GUD181 CAM181
ROB188 GUD188 CAM188

Recalling Firm/
Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation FL 33317-7424
For Additional Information Contact
954-927-2044 Ext. 605
Manufacturer Reason
for Recall
MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
FDA Determined
Cause 2
Software design
Action Mako Surgical Corporation sent an Important Medical Device Correction letter dated August 31, 2012, to all affected customers. The letter included specifics regarding the software issue and how the correction will take place. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them to establish the appropriate time for the upgrade .Customers were asked to return by fax an Acknowledgement Form to 954-927-0446, ATTN: Quality Assurance. For questions customers were instructed to call 954-628-0447. For questions regarding this recall call 954-927-2044, ext 605.
Quantity in Commerce 137 devices
Distribution Worldwide Distribution - USA including IL, OR, IA, AZ, CA, CO, FL, MS, OK, PA, WV, NC, TX, NY, GA, NJ, OH, WA, VA, MA, MD, WI, MI, NV, MO, AL, UT, RI, AR, LA, ID, IN, and TN and Internationally to Japan, Scotland, Italy, Singapore, Turkey, Hong Kong, and Korea.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.