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 rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
Recall
- Recall Number
- Z-0385-2013
- Event Number
- 63607
- Firm
- Mako Surgical Corporation
- FEI Number
- 3005985723
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- September 12, 2012
- Posted
- November 19, 2012
- Terminated
- May 22, 2013
- Address
- 2555 Davie Rd, Ste 110, Plantation, FL, 33317-7424
Description
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 rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
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.
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, ext 605.
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.
137 devices