BEUDAMED
    FDA Enforcement Class II Terminated

    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures

    Recall: Z-1619-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1619-2013
    Event ID
    65166
    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
    July 10, 2013
    Initiation Date
    March 6, 2013
    Classification Date
    July 1, 2013
    Termination Date
    July 22, 2013
    Address
    11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States

    Description

    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures

    Reason

    Incorrect blue/white suture was used.

    Code Info

    Product Number CFBC-4502, Lot #431437

    Distribution

    US Distribution including the states of FL, KY, LA, MI, NC, and NY.

    Quantity

    60 each of both units