BEUDAMED
    FDA Recall 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 · Initiated March 11, 2014

    Recall

    Recall Number
    Z-1296-2014
    Event Number
    67733
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GAT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 11, 2014
    Posted
    March 26, 2014
    Terminated
    August 15, 2017
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709

    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.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it 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 - U.S. Nationwide and the countries of Canada, Germany, and Ireland

    Quantity

    Total 32,271 ea.