Recall Z-0385-2013 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
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 ri
| Date | Nov 19, 2012 (initiated Sep 12, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Mako Surgical Corporation sent an Important Medical Device Correction letter dated August 31, 2012, to all affected customers. The letter included specifics regarding the software issue and how the correction will take place. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them to establish the appropriate time for the upgrade .Customers were asked to return by fax an Acknowledgement Form to 954-927-0446, ATTN: Quality Assurance. For questions customers were instructed to call 954-628-0447. For questions regarding this recall call 954-927-2044, |
| Quantity | 137 devices |
| Distribution | Worldwide Distribution - USA including IL, OR, IA, AZ, CA, CO, FL, MS, OK, PA, WV, NC, TX, NY, GA, NJ, OH, WA, VA, MA, MD, WI, MI, NV, MO, AL, UT, RI, AR, LA, ID, IN, and TN and Internationally to Japan, Scotland, Italy, Singapore, Turkey, Hong Kong, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 Mako Surgical Corp., Nov 25, 2008 |