BEUDAMED
    FDA Recall Terminated

    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch

    Recall: Z-0789-2013 · Initiated November 15, 2012

    Recall

    Recall Number
    Z-0789-2013
    Event Number
    63823
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 15, 2012
    Posted
    February 5, 2013
    Terminated
    May 22, 2013
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch

    Reason

    ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.

    Action

    ConMed Linvatech issued a "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to its customers on November 15, 2012 for a recall that was conducted at the end user/distributor level. All recall notifications were sent FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with reason for the recall 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. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169. For questions regarding this recall call 727-399-5205.

    Distribution

    Worldwide Distribution - USA including California and Internationally to Spain and Korea

    Quantity

    8