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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 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
Premarket Notification
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/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation, Florida 33317-7424
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
DESIGN: 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.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORP.
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