Device 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.
Z-3182-2018
Product summary
- Event
- Event 80762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 736 (US) and 174 (OUS)
- Official record key
device-enforcement:Z-3182-2018
Official wording
Reason: Communication-connection error.
Code information: ALL LOTS
Distribution pattern: 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,
Derived failure modes
-
Unknown
Communication-connection error.