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.
This recall has been terminated (originally issued February 19, 2015).
- Company
- Mako Surgical Corporation
- Recall Initiated
- January 22, 2015
- Posted
- February 19, 2015
- Terminated
- December 14, 2016
- Recall Number
- Z-1128-2015
- Quantity
- 228 units
- Firm Location
- Plantation, FL
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.
Lot / Code Info
All lots, Part Numbers: 201000, 203999, 207300, and 209930.
Root Cause
Device Design
Action Taken
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.