Company:Mako Surgical Corporation.
Date of Enforcement Report 9/20/2017
ClasslI:
PRODUCT
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Recall Number Z-3130-2017
REASON
Software discrepancy of not showing all the EE constants, when the screen is filled.
RECALLING FIRM/MANUFACTURER
Mako Surgical Corporation, Davie, FL on 8/7/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
349 (US) and 78 (OUS)
DISTRIBUTION
Nationwide and Internationally
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