BEUDAMED
    FDA Recall Terminated

    Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels for L2 to S1.

    Recall: Z-0151-2009 · Initiated August 18, 2008

    Recall

    Recall Number
    Z-0151-2009
    Event Number
    49439
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 18, 2008
    Posted
    October 20, 2008
    Terminated
    November 4, 2008
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels for L2 to S1.

    Reason

    The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.

    Action

    Urgent Product Recall notification letters were sent via Fed Express on August 18, 2008 to Stryker Branches and Hospital Risk Managers. The firm asked customers to examine their inventory and hospital locations to identify the product; reconcile all products on the Product Accountability Form and attached distribution sheet; and fax a copy of the Accountability Form and distribution sheet to Sarah Thompson within 5 days of receipt of the notice. All questions are to be directed to Susan Krasny at 201-760-8150.

    Distribution

    Nationwide Distribution

    Quantity

    69 units