Recall Z-2794-2018 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for u
| Date | May 10, 2018 |
| Status | Terminated |
| Reason | Out of tolerance. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker sent an Urgent Medical Device Removal letter dated May 14, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to sign the enclosed Recall Notification Business Reply Form and fax a copy to 1-855-741-4992 or email to strykerortho7035@stericycle.com. |
| Quantity | 10,606 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170891 | Mako Partial Knee Application Mako Surgical Corp., May 24, 2017 |