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Mako Surgical Corporation recalls Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is inte
Recalled September 20, 2017 · FDA recall Z-3130-2017 · Mako Surgical
Hazard
Software discrepancy of not showing all the EE constants, when the screen is filled. · FDA Class II
Units
349 (US) and 78 (OUS)
Sold at
Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey
Description
Software discrepancy of not showing all the EE constants, when the screen is filled.
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.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →