Recall Z-0288-2021 ยท OLO Orthopedic Stereotaxic Instrument
Blue Ortho
Instructions For Use document of the GPS Trackers.
| Date | Sep 10, 2020 |
| Status | Terminated |
| Reason | Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents. |
| Root cause | Other |
| Action | On 9/10/2020 the firm sent an Urgent Field Safety Notification to its consignees US FDA expressed concern with the appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents, leveraged from proper validation files. Based on this concern, Blue Ortho decided to revise the appropriateness of the language used in the Tracker reprocessing instruction LEFUS Tracker for Low Temperature Sterilization v1.0 to remove such conditions. Blue Ortho has already upda |
| Quantity | 3471 units |
| Distribution | Domestic Distribution Only: CA, CO, SC and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193618 | ExactechGPS System Blue Ortho, Sep 2, 2020 |