Recall Z-1847-2015 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use
| Date | Jun 26, 2015 (initiated May 26, 2015) |
| Status | Terminated |
| Reason | Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps. |
| Root cause | Error in labeling |
| Action | Consignees were notified via Urgent Medical Device Correction Notification on 5/26/15. The letter identified the affected product and described the issue. This field correction does not require the return of the subject products. Revised instructions for use are being provided to the identified consignees. |
| Quantity | 15,798 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.