BEUDAMED
    FDA Recall Terminated

    Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".

    Recall: Z-2153-2008 · Initiated June 29, 2007

    Recall

    Recall Number
    Z-2153-2008
    Event Number
    48466
    Firm
    Acumed LLC
    FEI Number
    1000125930
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 29, 2007
    Posted
    August 28, 2008
    Terminated
    February 3, 2010
    Address
    5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9370

    Description

    Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".

    Reason

    Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.

    Action

    The firm issued an Urgent Notification: Product Removal letter on 6-29-2007. The notification was reportedly sent by either FAX or e-mail. The notification informed consignees to remove the plates from their inventory and return them to Acumed. The notification did not include any instructions for a sub-recall. On 6/13/08, the firm sent a second Urgent Notification: Product Removal letter. This letter describes the product as PL-DR50L - Lot Code - W48003, explains the problem and asks customers to return product to Acumed.

    Distribution

    Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil.

    Quantity

    51 pieces