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.
Recall
- Recall Number
- Z-3182-2018
- Event Number
- 80762
- Firm
- Mako Surgical Corporation
- FEI Number
- 3005985723
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 27, 2017
- Terminated
- December 14, 2020
- Address
- 2555 Davie Rd, Ste 110, Davie, FL, 33317-7424
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.
Communication-connection error.
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.
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,
736 (US) and 174 (OUS)