Recall Z-3182-2018 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
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
| Date | Dec 27, 2017 |
| Status | Terminated |
| Reason | Communication-connection error. |
| Root cause | 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 | 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, |
| FDA record | Open on fda.gov |