Z-3131-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- August 7, 2017
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 291 (US) and 66 (OUS)
Product Description
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.
Reason for Recall
Software discrepancy of not showing all the EE constants, when the screen is filled.
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
Code Information
All Lot codes