Mako Surgical Corporation recalls Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated…

Recall date

July 16, 2015

Source

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

Recall number

Z-0224-2016

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece,…

Why it was recalled

The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

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

What was recalled

Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.