Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile; Manufactured by Stryker Spine, SA,
FDA device recall Z-0823-2010 · posted 2010-02-24 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- 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.
- Action taken
- 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 should be directed to Tiffani Rogers at 201-760-8206.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 21
- Distribution
- Nationwide Distribution -- IL, MO, DA, MA and CO.
- Date initiated
- 2009-12-30
- Date posted
- 2010-02-24
- Date terminated
- 2012-09-06
- 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 3 SPINAL SYSTEM (K083393) | Stryker Spine | 2009-04-01 |