Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, Franc
FDA device recall Z-1525-2009 · posted 2009-06-26 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.
- Action taken
- Market Withdrawal letters were sent to Stryker branches who received product on April 13, 2007 by Federal Express. The letters asked that they examine their inventory and hospital locations to identify the implant; reconcile these implants on the attached Product Accountability Form and fax a copy to (201) 760-8456; retrieve and return the affected implants; and contact their Stryker Customer Service rep to re-order the product that they are returning as part of the regulatory action.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 38 in US
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-04-12
- Date posted
- 2009-06-26
- Date terminated
- 2009-06-29
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM (K060361) | Stryker Spine | 2006-03-06 |