Recall Z-1190-2012 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
| Date | Mar 8, 2012 (initiated Feb 6, 2012) |
| Status | Terminated |
| Reason | When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra. |
| Root cause | Device Design |
| Action | An Urgent - Product Safety Notice customer letter was sent via FED EX on 2/6/12 and 2/6/12 to direct consignees in the US identifying the affected product and the issue with it. The letter states that Medtronic Navigation is removing the product from clinical use and will provide a sales credit to customers. In the letters to Medtronic field personnel, it states that local sales and service personnel will be identified to remove the affected product from customer sites and return them for scrapping. Customers are to contact a sales representative if they have any questions regarding the let |
| Quantity | 5 units |
| Distribution | Worldwide Distribution -- US and Republic of South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc., Apr 22, 1999 |