Recall Z-1128-2015— Mako Surgical Corporation
Class II · Terminated
Class II FDA medical device recall by Mako Surgical Corporation, initiated 2015-01-22, terminated 2016-12-14. It names one FDA 510(k) clearance: K112507. Product: 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.. Reason: 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.
- Recalling firm
- Mako Surgical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-22
- Terminated
- 2016-12-14
- Firm location
- Plantation, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.