{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114357", "product_res_number": "Z-0385-2013", "event_date_initiated": "2012-09-12", "event_date_posted": "2012-11-19", "recall_status": "Terminated", "event_date_terminated": "2013-05-22", "res_event_number": "63607", "product_code": "OLO", "k_numbers": [ "K081867" ], "product_description": "The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). \n 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_info": "ROB S/N\tGUD S/N\tCAM S/N ROB036\tGUD054\tCAM054 ROB037\tGUD043\tCAM037 ROB038\tGUD038\tCAM038 ROB039\tGUD039\tCAM039 ROB040\tGUD040\tCAM035 ROB042\tGUD042\tCAM043 ROB046\tGUD046\tCAM046 ROB047\tGUD044\tCAM047 ROB048\tGUD047\tCAM048 ROB049\tGUD048\tCAM049 ROB051\tGUD074\tCAM074 ROB053\tGUD053\tCAM053 ROB054\tGUD091\tCAM091 ROB055\tGUD055\tCAM075 ROB056\tGUD056\tCAM066 ROB057\tGUD058\tCAM058 ROB059\tGUD059\tCAM059 ROB060\tGUD060\tCAM060 ROB061\tGUD061\tCAM061 ROB062\tGUD063\tCAM062 ROB063\tGUD062\tCAM063 ROB065\tGUD065\tCAM033 ROB066\tGUD057\tCAM057 ROB067\tGUD067\tCAM067 ROB069\tGUD036\tCAM036 ROB070\tGUD070\tCAM055 ROB071\tGUD083\tCAM083 ROB072\tGUD072\tCAM072 ROB074\tGUD102\tCAM102 ROB075\tGUD103\tCAM103 ROB076\tGUD045\tCAM045 ROB078\tGUD082\tCAM082 ROB079\tGUD076\tCAM076 ROB080\tGUD071\tCAM071 ROB081\tGUD075\tCAM070 ROB083\tGUD069\tCAM069 ROB084\tGUD100\tCAM100 ROB085\tGUD079\tCAM079 ROB086\tGUD086\tCAM086 ROB088\tGUD088\tCAM088 ROB089\tGUD089\tCAM089 ROB090\tGUD080\tCAM081 ROB091\tGUD098\tCAM098 ROB092\tGUD051\tCAM051 ROB093\tGUD085\tCAM085 ROB094\tGUD094\tCAM094 ROB095\tGUD095\tCAM095 ROB096\tGUD125\tCAM125 ROB097\tGUD097\tCAM097 ROB098\tGUD093\tCAM093 ROB099\tGUD099\tCAM099 ROB100\tGUD081\tCAM080 ROB101\tGUD101\tCAM101 ROB102\tGUD077\tCAM077 ROB103\tGUD078\tCAM078 ROB104\tGUD104\tCAM104 ROB106\tGUD106\tCAM106 ROB107\tGUD107\tCAM107 ROB108\tGUD108\tCAM108 ROB109\tGUD109\tCAM109 ROB110\tGUD110\tCAM110 ROB111\tGUD111\tCAM112 ROB112\tGUD105\tCAM111 ROB114\tGUD113\tCAM105 ROB116\tGUD115\tCAM116 ROB117\tGUD116\tCAM115 ROB118\tGUD117\tCAM117 ROB119\tGUD118\tCAM119 ROB120\tGUD119\tCAM118 ROB121\tGUD120\tCAM120 ROB122\tGUD121\tCAM121 ROB123\tGUD122\tCAM122 ROB124\tGUD123\tCAM123 ROB125\tGUD124\tCAM124 ROB126\tGUD126\tCAM126 ROB127\tGUD127\tCAM127 ROB129\tGUD129\tCAM129 ROB130\tGUD130\tCAM130 ROB131\tGUD084\tCAM084 ROB133\tGUD133\tCAM133 ROB134\tGUD134\tCAM134 ROB135\tGUD135\tCAM135 ROB136\tGUD136\tCAM136 ROB140\tGUD140\tCAM140 ROB141\tGUD141\tCAM141 ROB143\tGUD143\tCAM143 ROB145\tGUD145\tCAM145 ROB146\tGUD146\tCAM146 ROB147\tGUD147\tCAM147 ROB148\tGUD148\tCAM148 ROB149\tGUD149\tCAM149 ROB150\tGUD150\tCAM150 ROB151\tGUD151\tCAM151 ROB152\tGUD152\tCAM152 ROB153\tGUD153\tCAM153 ROB154\tGUD154\tCAM154 ROB155\tGUD155\tCAM155 ROB156\tGUD156\tCAM156 ROB158\tGUD158\tCAM158 ROB159\tGUD159\tCAM159 ROB160\tGUD160\tCAM160 ROB161\tGUD161\tCAM161 ROB163\tGUD163\tCAM163 ROB164\tGUD164\tCAM164 ROB165\tGUD165\tCAM165 ROB167\tGUD167\tCAM167 ROB170\tGUD170\tCAM170 ROB171\tGUD131\tCAM131 ROB172\tGUD172\tCAM172 ROB173\tGUD173\tCAM173 ROB175\tGUD175\tCAM175 ROB176\tGUD176\tCAM176 ROB177\tGUD177\tCAM177 ROB178\tGUD178\tCAM178 ROB180\tGUD180\tCAM180 ROB182\tGUD182\tCAM182 ROB183\tGUD183\tCAM183 ROB187\tGUD187\tCAM187 ROB191\tGUD192\tCAM191 ROB192\tGUD193\tCAM193 ROB193\tGUD191\tCAM192 ROB203\tGUD203\tCAM203 ROB204\tGUD204\tCAM204 ROB205\tGUD205\tCAM205 ROB206\tGUD206\tCAM206 ROB207\tGUD207\tCAM207 ROB050\tGUD050\tCAM050 ROB058\tGUD066\tCAM056 ROB073\tGUD073\tCAM073 ROB082\tGUD037\tCAM042 ROB137\tGUD137\tCAM137 ROB144\tGUD144\tCAM144 ROB168\tGUD168\tCAM168 ROB169\tGUD169\tCAM169 ROB181\tGUD181\tCAM181 ROB188\tGUD188\tCAM188", "firm_fei_number": "3005985723", "recalling_firm": "Mako Surgical Corporation", "address_1": "2555 Davie Rd Ste 110 2555 Davie Rd", "address_2": "Ste 110", "city": "Plantation", "state": "FL", "postal_code": "33317-7424", "additional_info_contact": "954-927-2044 Ext. 605", "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.", "root_cause_description": "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.\nFor questions regarding this recall call 954-927-2044, ext 605.", "product_quantity": "137 devices", "distribution_pattern": "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.", "openfda": { "k_number": [ "K233443", "K162364", "K181449", "K233706", "K261113", "K261410", "K203679", "K211616", "K201327", "K162567", "K162921", "K152574", "K193135", "K200935", "K240625", "K151364", "K111843", "K090420", "K182982", "K260546", "K250879", "K223070", "K254157", "K240647", "K223558", "K212088", "K233595", "K192336", "K212825", "K221928", "K183381", "K232572", "K240160", "K193515", "K223108", "K170430", "K243514", "K180816", "K222698", "K173946", "K130748", "K251780", "K233228", "K212028", "K163581", "K173372", "K181111", 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