Recall Z-0603-2018 ยท OLO Orthopedic Stereotaxic Instrument
Exactech, Inc.
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
| Date | Jan 18, 2018 (initiated Jul 11, 2017) |
| Status | Terminated |
| Reason | Vix Bit may fracture during use. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified on approximately 07/11/2017. Instructions included cease distribution of the affected product, notify customers if further distributed, identify and quarantine any product in inventory and complete and return the Recall Inventory Response Form. For further questions, please call (800) 392-2832. |
| Quantity | 41 devices |
| Distribution | Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software Blue Ortho, Apr 5, 2017 |