Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usa...
FDA Recall #Z-3182-2018 — Class II — December 27, 2017
Product Description
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.
Reason for Recall
Communication-connection error.
Recalling Firm
Mako Surgical Corporation — Davie, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
736 (US) and 174 (OUS)
Distribution
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,
Code Information
ALL LOTS
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated