Recall Z-0146-2012 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
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
| Date | Nov 1, 2011 (initiated Jan 20, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA Mako Surgical Corp., Feb 24, 2010 |