BEUDAMED
    FDA Enforcement Class II Terminated

    Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

    Recall: Z-1296-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1296-2014
    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

    Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

    Reason

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

    Code Info

    Product Code: X-6371M5, Lot numbers: 02E0801603

    Distribution

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

    Quantity

    Total 32,271 ea.