BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0823-2010 · Initiated December 30, 2009

    Recall

    Recall Number
    Z-0823-2010
    Event Number
    54271
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 30, 2009
    Posted
    February 24, 2010
    Terminated
    September 6, 2012
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    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.

    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.

    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 should be directed to Tiffani Rogers at 201-760-8206.

    Distribution

    Nationwide Distribution -- IL, MO, DA, MA and CO.

    Quantity

    21