Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Hazard
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
What You Should Do
Remedy
On January 22, 2015 the firm sent an IMPORTANT MEDICAL DEVICE CORRECTION asking consignees to complete the attached acknowledgement form and return them by email, fax or mail. The notice also noted the RIO system can continue to be used. The likelihood of occurrence is rare (.035% of cases) and the event is readily detectable and can be resolved. Should you have any questions regarding this Important Medical Device Recall Notice, to contact us at (954) 628-1721.
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Products
Restoris Partial Knee Application (PKA) RIO (TGS 2.0).
For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
- Brand
- Mako Surgical Corporation
- UPC
- All lots, Part Numbers: 201000, 203999, 207300, and 209930.
Units Affected
228 units