Company:Mako Surgical Corp
Date of Enforcement Report 11/23/11
Class l:
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. 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. Recall Z-0146-2012
REASON
Software issue that exist that could potentially result in a bone resection. No adverse events reporyed.
RECALLING FIRM/MANUFACTURER
Mako Surgical Corp., Davie, FL, by letter dated February 1, 2011, Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
68 units
DISTRIBUTION
Nationwide and Scotland, Italy and Korea
