Recall Z-1149-2020 ยท OLO Orthopedic Stereotaxic Instrument
Blue Ortho
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
| Date | Sep 22, 2019 |
| Status | Terminated |
| Reason | The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded). |
| Root cause | Software design |
| Action | Blue Ortho issued an Advisory Notice via email on September 22, 2019 stating the reason for recall, health risk and action to take: The issue happens only with the LPI instrumentation. There is no issue with the Truliant instrumentation. Therefore, Blue Ortho ask the user: To use the TKA Pro 2.1 software application with the Truliant instrumentation only, To NOT change the instrumentation once the protocol is started. Do not click on Change instrument nor Change to LPI.If the Truliant instrumentation is not available, the TKA Pro 2.1 software application must not be used. Blue Ortho will deli |
| Quantity | 7 units |
| Distribution | AZ, CA, FL, TN Foreign: Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152764 | EXACTECH GPS Blue Ortho, Jul 13, 2016 |