BEUDAMED
    FDA Recall Terminated

    Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

    Recall: Z-1535-2014 · Initiated March 11, 2014

    Recall

    Recall Number
    Z-1535-2014
    Event Number
    67973
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2014
    Posted
    May 1, 2014
    Terminated
    March 29, 2016
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709

    Description

    Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

    Reason

    The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

    Action

    Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.

    Quantity

    7,380 ea (total)