Recall Z-0823-2010
Stryker Spine · initiated December 30, 2009
Product
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.
Codes / lots: Lot number: A91109
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0823-2010
- Initiated
- December 30, 2009
- Posted by FDA
- February 24, 2010
- Terminated
- September 6, 2012
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 21
- Distribution
- Nationwide Distribution -- IL, MO, DA, MA and CO.
- Recalling firm
- Stryker Spine, Allendale, NJ