BEUDAMED
    FDA Recall 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 · Initiated April 9, 2012

    Recall

    Recall Number
    Z-0164-2013
    Event Number
    63090
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 9, 2012
    Posted
    October 29, 2012
    Terminated
    November 21, 2013
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    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.

    Action

    Linvatec Corp sent a Urgent Medical Device Recall Notification letter dated April 9, 2012, to all affected customers. The letter was sent via FEDEx and by e-mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory for the recalled product and segregate them for return to the recalling firm. Furthermore, return the products along with the "REPLY FORM". Should you have any further questions please contact our Customer Service department at (800) 237-0169.

    Distribution

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

    Quantity

    2 units