BEUDAMED
    FDA Enforcement Class II Terminated

    CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.

    Recall: Z-2147-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2147-2012
    Event ID
    62395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Linvatec Corp. dba ConMed Linvatec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 15, 2012
    Initiation Date
    August 12, 2011
    Classification Date
    August 6, 2012
    Termination Date
    November 21, 2013
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908, United States

    Description

    CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.

    Reason

    ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.

    Code Info

    Lot #156920

    Distribution

    Nationwide Distribution, including the states of Colorado and Pennsylvania.

    Quantity

    2