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U.S. Department of Health and Human Services

Class 2 Device Recall RIO Robot Arm Interactive Orthopedic System

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  Class 2 Device Recall RIO Robot Arm Interactive Orthopedic System see related information
Date Initiated by Firm January 20, 2011
Date Posted November 01, 2011
Recall Status1 Terminated 3 on December 13, 2011
Recall Number Z-0146-2012
Recall Event ID 58162
510(K)Number K093425  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 DAVIE ROAD, FT. LAUDERDALE, FL 33317.

RIO System - The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be approriate, and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
Code Information Lot numbers: ROB034, ROB035, ROB036, ROB037, ROB038, ROB042, ROB044, ROB045, ROB046, ROB047, ROB048, ROB049, ROB050, ROB051, ROB053, ROB054, ROB055, ROB056, ROB057, ROB059, ROB060, ROB061, ROB062, ROB062, ROB063, ROB066, ROB067, ROB069, ROB070, ROB071, ROB072, ROB073, ROB074, ROB075, ROB076, ROB077, ROB078, ROB079, ROB080, ROB081, ROB082, ROB083, ROB084, ROB085, ROB086, ROB088, ROB093, ROB094, ROB096, ROB097, ROB098, ROB099, ROB100, ROB101, ROB102, ROB103, ROB104, ROB107, ROB108, ROB109, ROB110, ROB112, ROB114, ROB116, ROB117, ROB118, ROB120, ROB121, ROB122, ROB123, ROB124.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Rachele Riviere
954-927-2044 Ext. 605
Manufacturer Reason
for Recall		 MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software issue that exist that could potentially result in a bone resection. No adverse events reported.
FDA Determined
Cause 2		 Software change control
Action The firm, MAKO Surgical Corp., sent an "RECALL NOTICE 2.4. SITES" letter dated February 1, 2011 to its customers. The letter describes the product, problem, actions to be taken which includes a workaround and an updated user guide identifying the appropriate workflow. The customers were instructed to follow the user guide and workflow and to complete and return the enclosed confirmation memo to their MAKOplasty Specialist or return it in the pre-addressed, pre-paid envelope provided. MAKOplasty included with the letter new steps in the surgical workflow in the use of the RIO system to ensure error value accuracy; worked on a software update that will not allow the user to proceed with error values that do not support the required accuracy-this software was to be supplied to customers in February 2011, and trained MAKOplasty Specialist will make available written updates to the RIO use instructions as well. If you have any questions or concerns, please do not hesitate to speak with your MAKOplasty Specialist or contact the Manager of Customer Relations at 954.927.4022 x447.
Quantity in Commerce 70
Distribution Worldwide distribution: USA including states of: AZ, CA, CO, FL, GA, IA, IL, LA, MI, MO, MS, NC, NJ, NV, NY, OK, OH, OR, PA, RI, TX, UT, VA, WA, WI, and WV; and countries of: Scotland, Italy and Korea.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORP.
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