BEUDAMED
    FDA Recall Terminated

    "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    Recall: Z-0066-2013 · Initiated June 26, 2012

    Recall

    Recall Number
    Z-0066-2013
    Event Number
    63115
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 26, 2012
    Posted
    October 15, 2012
    Terminated
    October 3, 2014
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    Reason

    Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.

    Action

    ConMed Linvatec sent an Urgent Medical Device Recall Notification letter on June 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility for the recalled products, segregate them for return to ConMed Linvatec. The customers were also told to return the REPLY FORM to the Regulatory Department at the firm. For questions customers were instructed to call 800-237-0169 or email at [email protected]. For questions regarding this recall call 727-392-6464.

    Distribution

    Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL

    Quantity

    879 units for all products in recall event