Company: Mako Surgical Corporation
Date of Enforcement Report 11/28/12
Class ll:
PRODUCT
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 Number Z-0385-2013
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.
RECALLING FIRM/MANUFACTURER
Mako Surgical Corporation, Plantataion, FL on 9/12/2012 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
137 devices
DISTRIBUTION
Nationwide and Internationally
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