Recall Z-3130-2017 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
| Date | Aug 7, 2017 |
| Status | Terminated |
| Reason | Software discrepancy of not showing all the EE constants, when the screen is filled. |
| Root cause | Software design |
| Action | There will be no communication to the customer. Notification shall only go to the MAKO Product Specialist and Branch Managers as this action is not a customer facing issue. These letters and acknowledge forms were sent via Federal Express Two Days Air with return receipt. |
| Quantity | 349 (US) and 78 (OUS) |
| Distribution | Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong |
| 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 |