FDA Device recall Z-0385-2013

The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000)

FDA Device
Class II
terminated
Published 2012-11-28

On 2012-11-28 the FDA classified a Class II recall of The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000) by Mako Surgical, citing 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 th….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0385-2013
Classification	Class II
Status	terminated
Initiated	2012-09-12
Published	2012-11-28
Last updated	2026-09-13 11:53 UTC
Company	Mako Surgical
Distribution	AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV

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).

Reason

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.

Identifiers

code_info	ROB S/N GUD S/N CAM S/N ROB036 GUD054 CAM054 ROB037 GUD043 CAM037 ROB038 GUD038 CAM038 ROB039 GUD039 CAM039 ROB040… 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

code_info

ROB S/N GUD S/N CAM S/N ROB036 GUD054 CAM054 ROB037 GUD043 CAM037 ROB038 GUD038 CAM038 ROB039 GUD039 CAM039 ROB040…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0385-2013%22

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