StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) Catalog number: 11-1525 The StaXx X
FDA device recall Z-0967-2011 · posted 2011-01-26 · Terminated
Recall details
- Recalling firm
- Spine Wave Inc
- Reason for recall
- Package Insert Incorrect
- Action taken
- Spine Wave notified each affected customer on October 22,2010, via telephone of the product, the issue and action they should take. Customers were asked to segregate the product from other products and immediately return to Spine Wave. For questions regarding this recall call 203-944-9494.
- Root cause
- Packaging process control
- Status
- Terminated
- Quantity affected
- 12 units
- Distribution
- Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York
- Date initiated
- 2010-10-22
- Date posted
- 2011-01-26
- Date terminated
- 2011-03-15
- Location
- Shelton, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAXX XD SYSTEM (K101288) | Spine Wave, Inc. | 2010-09-10 |