BEUDAMED
    FDA Recall Terminated

    PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.

    Recall: Z-2151-2012 · Initiated July 6, 2012

    Recall

    Recall Number
    Z-2151-2012
    Event Number
    62665
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    July 6, 2012
    Posted
    August 6, 2012
    Terminated
    November 21, 2013
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.

    Reason

    ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.

    Action

    The recall is being conducted to the end user level. ConMed Linvatec Urgent Medical Device Recall Notifications were sent by FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with the reason for the recall and health risk. All accounts were asked to immediately check their facility for the affected product, stop using any of the product with specified lot number, and to segregate the product. The letter also asked customers to return all affected product to ConMed Linvatec and respond using a Reply Form, even if there is no affected product available. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169.

    Distribution

    Worldwide Distribution -- US and Korea.

    Quantity

    2