Mako Surgical Corporation recalls Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee A

Recalled September 26, 2018 · FDA recall Z-3182-2018 · Mako Surgical

Hazard

Communication-connection error. · FDA Class II

Units

736 (US) and 174 (OUS)

Sold at

Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,

Description

Communication-connection error.

Product

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, 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 →