Recall Z-2741-2017 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
| Date | Jun 7, 2017 |
| Status | Terminated |
| Reason | An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. |
| Root cause | Employee error |
| Action | Customers were sent notices titled "Urgent Medical Device Correction Notification" on 06/12/2017 via UPS Next Day Mail. The firm notifies consignees of the reason for recall and instructs that users of the recalled product be provided the recall notice. Users may continue to use their MAKO system; and, Stryker/MAKO Service personnel will contact users o schedule time to inspect and replace the card cage, if necessary. Also, users are instructed to return the completed Business Reply Form within 5 business days. The completed form can be sent to strykerortho7391@stericycle.com or faxed to 8 |
| Quantity | 20 |
| Distribution | Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA. |
| 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 |