Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin,
FDA device recall Z-2335-2010 · posted 2010-08-31 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
- Action taken
- The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice. For questions or assistance, please contact Zimmer Spine at 800-326-0635.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 691
- Distribution
- Worldwide.
- Date initiated
- 2009-01-12
- Date posted
- 2010-08-31
- Date terminated
- 2010-12-22
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS (K071174) | Abbott Spine, Inc. | 2007-07-25 |
| SPINAL CONCEPTS INC. PATHFINDER (K030625) | Spinal Concepts, Inc. | 2003-03-28 |