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.
Reported: September 20, 2017 Initiated: August 7, 2017 #Z-3131-2017
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.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 291 (US) and 66 (OUS)
- 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
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mako Surgical Corporation. Units affected: 291 (US) and 66 (OUS).
Why was this product recalled? ▼
Software discrepancy of not showing all the EE constants, when the screen is filled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2017. Severity: Moderate. Recall number: Z-3131-2017.
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