Recall Z-0849-2008 ยท HAW Neurological Stereotaxic Instrument
Medtronic Image Guided Neurologics, Inc.
Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL, DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042, DB-2042-BL, DB-2042-ST, DB-2043, DB-2043-BL, DB-2043-ST,, Medtronic, Inc, Minneapolis, Minnesota
| Date | Feb 7, 2008 (initiated Oct 4, 2007) |
| Status | Terminated |
| Reason | Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured. |
| Root cause | Package design/selection |
| Action | On 10/4/2007, consignees were notified by Medtronic field personnel, either by personal visits or telephone. All wholesalers of this product are OUS. Medtronic OUS Regulatory personnel communicated this issue directly to the wholesalers, who provided the letters to their customers. Medtronic field personnel are responsible for completing and returning reply cards confirming all notifications (100%). |
| Quantity | 385 |
| Distribution | Worldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012366 | NAVIGUS II TRAJECTORY GUIDE Image-Guided Neurologics, Inc., Oct 1, 2001 |
| K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 Image-Guided Neurologics, Inc., Sep 25, 2002 |
| K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 Image-Guided Neurologics, Inc., Oct 4, 2004 |
| K043091 | NAVIGUS NEXDRIVE, MODEL MI-3000 Image-Guided Neurologics, Inc., Feb 7, 2005 |