BEUDAMED
    FDA Recall Terminated

    Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.

    Recall: Z-1602-2010 · Initiated May 19, 2009

    Recall

    Recall Number
    Z-1602-2010
    Event Number
    55184
    Firm
    Acumed LLC
    FEI Number
    1000125930
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 19, 2009
    Posted
    May 14, 2010
    Terminated
    May 17, 2010
    Address
    5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9432

    Description

    Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.

    Reason

    Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw

    Action

    On May 18, 2009, the firm, ACUMED, began calling customers. On May 19, 2009, the ACUMED sent e-mails and a "URGENT NOTICE: DEVICE RECALL" Initial Notice letter to all customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to identify the product having the lot code(s) and quarantine them, return all products from the lot code(s) to Acumed immediately, to please notify the customers of this recall if you further distributed this product, and complete and return the Acumed Product Recall Effectiveness Form. Please contact Acumed Customer Service at 1-888-627-9957 for any questions regarding this notification.

    Distribution

    Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan

    Quantity

    83