BEUDAMED
    FDA Enforcement Class II Terminated

    Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.

    Recall: Z-1291-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1291-2014
    Event ID
    67733
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2014
    Initiation Date
    March 11, 2014
    Classification Date
    March 25, 2014
    Termination Date
    August 15, 2017
    Address
    2917 Weck Dr., N/A, Research Triangle Park, NC, 27709, United States

    Description

    Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.

    Reason

    The products are being recalled because they did not meet minimum needle attachment strength requirements.

    Code Info

    Product Code: 1154654, Lot number: 02K0801212

    Distribution

    Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

    Quantity

    Total 32,271 ea.