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

Recalled November 11, 2015 · FDA recall Z-0224-2016 · Mako Surgical

Hazard

The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. · FDA Class II

Units

1,322 units

Sold at

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, Australia, Singapore, Taiwan, and South Korea.

Description

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

Product

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.

Manufacturer(s)

Mako Surgical Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →