Mako Surgical Corporation recalls Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO)…

Recall date

January 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1128-2015

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.

Why it was recalled

When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.