| Class 2 Device Recall Makoplasty RIO Standard System | |
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 | K170581 K170584 K170593 K170891 |
Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = OLO
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