The RIO (TGS 2.)
Medical device recall Z-0385-2013. Published in FDA’s Enforcement Report on Nov 28, 2012.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 28, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 33 states named in where it went
- 137 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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).
137 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 2,879 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
33 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- Mississippi
- North Carolina
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 12, 2012.
- FDA classified it on Nov 19, 2012.
- FDA’s Enforcement Report published it on Nov 28, 2012.
- FDA terminated it on May 22, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Mako Surgical Corporation, of Plantation, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,879 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.