Recall Z-1508-2016 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
Robotic Arm Interactive Orthopedic System (RIO)
| Date | Apr 18, 2016 (initiated Apr 30, 2014) |
| Status | Terminated |
| Reason | Revision of the field manual |
| Root cause | Process control |
| Action | As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only. |
| Quantity | 249 |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea. |
| FDA record | Open on fda.gov |