{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plantation",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63607",
      "recalling_firm": "Mako Surgical Corporation",
      "address_1": "2555 Davie Rd Ste 110",
      "address_2": "N/A",
      "postal_code": "33317-7424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-0385-2013",
      "product_description": "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).",
      "product_quantity": "137 devices",
      "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.",
      "recall_initiation_date": "20120912",
      "center_classification_date": "20121119",
      "termination_date": "20130522",
      "report_date": "20121128",
      "code_info": "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"
    }
  ]
}