Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld instruments used
FDA device recall Z-1190-2012 · posted 2012-03-08 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 5 units
- Distribution
- Worldwide Distribution -- US and Republic of South Korea.
- Date initiated
- 2012-02-06
- Date posted
- 2012-03-08
- Date terminated
- 2012-03-26
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM (K990214) | Surgical Navigation Technologies, Inc. | 1999-04-22 |