PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
FDA device recall Z-0004-2008 · posted 2007-10-02 · Terminated
Recall details
- Recalling firm
- Abbott Spine
- Reason for recall
- Tip of PathFinder surgical instrument broke during procedure.
- Action taken
- Firm notified sales representatives with an approved phone script on 7/18/2007.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 11 units
- Distribution
- Nationwide.
- Date initiated
- 2007-07-18
- Date posted
- 2007-10-02
- Date terminated
- 2008-04-02
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINAL CONCEPTS INC. PATHFINDER (K030625) | Spinal Concepts, Inc. | 2003-03-28 |