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.
This recall has been terminated (originally issued November 1, 2011).
- Company
- Mako Surgical Corporation
- Recall Initiated
- January 20, 2011
- Posted
- November 1, 2011
- Terminated
- December 13, 2011
- Recall Number
- Z-0146-2012
- Quantity
- 70
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Software change control
Action Taken
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.