BEUDAMED
    FDA Recall Terminated

    Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S

    Recall: Z-0594-2009 · Initiated September 26, 2008

    Recall

    Recall Number
    Z-0594-2009
    Event Number
    50111
    Firm
    Ossur Grjothals 5 Reykjavik Ireland
    FEI Number
    3003764610
    Product Code
    LYT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 26, 2008
    Posted
    January 2, 2009
    Terminated
    April 27, 2010

    Description

    Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S

    Reason

    Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.

    Action

    Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008 with the Product Manager for this device contacting each consignee by phone. The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does not currently have replacement product available, but they will contact them immediately when they are available. If the products were not located, they were asked to determine where these pins are currently located, if they have been applied to a patient? If so, are they able to track down that patient and bring them in for an evaluation?

    Distribution

    Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

    Quantity

    27 pouches (1 pin/per pouch) = 27 pins