BEUDAMED
    FDA Recall Terminated

    Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".

    Recall: Z-2140-2008 · Initiated March 28, 2008

    Recall

    Recall Number
    Z-2140-2008
    Event Number
    48465
    Firm
    Acumed LLC
    FEI Number
    1000125930
    Product Code
    JDQ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 28, 2008
    Posted
    August 22, 2008
    Terminated
    February 3, 2010
    Address
    5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9432

    Description

    Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".

    Reason

    Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.

    Action

    On 3/28/08, the firm sent an Urgent Notification letter to their consignees. The letter explained the issue and requested the customers return the product to Acumend. On 7/16/08, the firm sent a 2nd notification, via mail, to thier customers. The Urgent Notice: Device Recall 2nd Notification, advised customers of the recall, the hazard and requested customers to return existing product to Acumed.

    Distribution

    Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.

    Quantity

    50 units