Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held 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.
Recall
- Recall Number
- Z-1189-2012
- Event Number
- 61173
- Firm
- Medtronic Navigation, Inc.
- FEI Number
- 1000517638
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 6, 2012
- Posted
- March 8, 2012
- Terminated
- March 26, 2012
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710
Description
Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held 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.
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.
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 letter.
Worldwide Distribution -- US and Republic of South Korea.
6 units