BEUDAMED
    FDA Recall Terminated

    Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48

    Recall: Z-1509-2014 · Initiated March 11, 2014

    Recall

    Recall Number
    Z-1509-2014
    Event Number
    67972
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    NEW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 11, 2014
    Posted
    April 25, 2014
    Terminated
    September 25, 2017
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709

    Description

    Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48

    Reason

    Product does not meet minimum knot tensile strength requirements.

    Action

    Consignees were notified by an Urgent Medical Device Recall Notification letter, dated 3/11/2014. The letter identified the affected product and the reason for recall. Customers were instructed to immediately discontinue use of and quarantine any affected product in stock. The affected product is to be returned; and the Recall Acknowledgement Form should be completed and faxed to the number provided regardless of whether customers have affected product in stock. Questions should be directed to a local sales rep or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide Distribution -- USA, including the state of MA, and the country of Germany

    Quantity

    3,072 ea.