Home / Recalls / Medical Devices
Mako Surgical Corporation recalls Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use wit
Recalled August 22, 2018 · FDA recall Z-2794-2018 · Mako Surgical
Hazard
Out of tolerance. · FDA Class II
Units
10,606
Sold at
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, Netherlands, Singapore, and United Kingdom
Description
Out of tolerance.
Product
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →