Recall Z-0823-2010 ยท NKB Thoracolumbosacral Pedicle Screw System
Stryker Spine
Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile; Manufactured by Stryker Spine, SA, Cestas, France. Distributed in the USA by Stryker Spine, Allendale, NJ Intended for use in the noncervical spine.
| Date | Feb 24, 2010 (initiated Dec 30, 2009) |
| Status | Terminated |
| Reason | The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws. |
| Root cause | Process control |
| Action | Stryker Spine branches that received the recalled product were notified of the recall by an Urgent Product Recall letter, dated January 15, 2010, sent via Federal Express. The letter identified the affected product and the issue involved. It also discussed the potential hazards, risk mitigation, and the return process. Customers are to examine their inventory and hospital locations to identify the product. Customers are also to reconcile the product by utilizing the Customer Response Form and distribution sheet. In addition, they are to retrieve and return the affected product. Questions |
| Quantity | 21 |
| Distribution | Nationwide Distribution -- IL, MO, DA, MA and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083393 | XIA 3 SPINAL SYSTEM Stryker Spine, Apr 1, 2009 |