BEUDAMED
    FDA Enforcement Class II Terminated

    "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.

    Recall: Z-0164-2013 · Reported November 7, 2012

    Enforcement

    Recall Number
    Z-0164-2013
    Event ID
    63090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Linvatec Corp. dba ConMed Linvatec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 7, 2012
    Initiation Date
    April 9, 2012
    Classification Date
    October 29, 2012
    Termination Date
    November 21, 2013
    Address
    11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States

    Description

    "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.

    Reason

    ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.

    Code Info

    Lot # 330889 and Catalog: PFT-00M - No Expiration date

    Distribution

    Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand

    Quantity

    2 units