Device product
Total Hip Application (THA) 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.
Z-3131-2017
Product summary
- Event
- Event 77950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 291 (US) and 66 (OUS)
- Official record key
device-enforcement:Z-3131-2017
Official wording
Reason: Software discrepancy of not showing all the EE constants, when the screen is filled.
Code information: All Lot codes
Distribution pattern: 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
Derived failure modes
-
Unknown
Software discrepancy of not showing all the EE constants, when the screen is filled.