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.
This recall has been terminated (originally issued August 7, 2017).
- Company
- Mako Surgical Corporation
- Recall Initiated
- August 7, 2017
- Terminated
- August 6, 2019
- Recall Number
- Z-3131-2017
- Quantity
- 291 (US) and 66 (OUS)
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Software discrepancy of not showing all the EE constants, when the screen is filled.
Distribution
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
Lot / Code Info
All Lot codes
Root Cause
Software design
Action Taken
There will be no communication to the customer. Notification shall only go to the MAKO Product Specialist and Branch Managers as this action is not a customer facing issue. These letters and acknowledge forms were sent via Federal Express Two Days Air with return receipt.