Recall Z-1525-2009 ยท NKB Thoracolumbosacral Pedicle Screw System
Stryker Spine
Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France; Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430 Single use device sterilized prior to use. For anterior/anterolateral and posterior noncervical pedicle and non-pedicle fixation for the following: degenerative disc disease, spondylolisthesis, trauma, spinal stenosi
| Date | Jun 26, 2009 (initiated Apr 12, 2007) |
| Status | Terminated |
| Reason | Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 38 in US |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060361 | XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM Stryker Spine, Mar 6, 2006 |