Recall Z-1128-2015 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
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.
| Date | Feb 19, 2015 (initiated Jan 22, 2015) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 228 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112507 | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM Mako Surgical Corporation, Mar 1, 2012 |