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.
This recall has been terminated (originally issued December 27, 2017).
- Company
- Mako Surgical Corporation
- Recall Initiated
- December 27, 2017
- Terminated
- December 14, 2020
- Recall Number
- Z-3182-2018
- Quantity
- 736 (US) and 174 (OUS)
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Communication-connection error.
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,
Lot / Code Info
ALL LOTS
Root Cause
Nonconforming Material/Component
Action Taken
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.
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