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U.S. Department of Health and Human Services

Class 2 Device Recall Makoplasty RIO Standard System

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  Class 2 Device Recall Makoplasty RIO Standard System see related information
Date Initiated by Firm December 27, 2017
Create Date September 15, 2018
Recall Status1 Terminated 3 on December 14, 2020
Recall Number Z-3182-2018
Recall Event ID 80762
510(K)Number K170891  K170584  K170593  K170581  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
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.
Code Information ALL LOTS
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Customer Service
954-628-7000
Manufacturer Reason
for Recall
Communication-connection error.
FDA Determined
Cause 2
Nonconforming Material/Component
Action A customer Notification letters and Product Correction Acknowledgement Forms will be sent to affected customers via UPS Day Air return receipt. Customers where informed that the affected products will be replaced.
Quantity in Commerce 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,
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO Surgical Corp.
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