Recall Z-1693-2020 ยท OLO Orthopedic Stereotaxic Instrument
Medtronic Navigation, Inc.
NavLock Tracker *** Rx Only
| Date | Apr 10, 2020 (initiated Aug 28, 2019) |
| Status | Terminated |
| Reason | Product was incorrectly assembled which could affect navigation accuracy of the device. |
| Root cause | Employee error |
| Action | On 08/28/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to its customer informing them of the manufacturing issue (incorrect assembly) and instructed them to: 1. Examine their inventory, and immediately quarantine the affected NavLock" Tracker and to return to the Recalling Firm. 2. To contact the Recalling Firm at 1-888-826-5603 to receive a return material authorization (RMA) and to arrange for return and a no-charge replacement. Once an RMA number is obtained, ship the affected product to Medtronic Product Services, 1480 Arthur Ave, Louisville CO 80027. 3. Follow instru |
| Quantity | 1 unit |
| Distribution | U.S.: NY No O.U.S. |
| FDA record | Open on fda.gov |