BEUDAMED
    FDA Recall Terminated

    Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G

    Recall: Z-1012-2007 · Initiated June 6, 2007

    Recall

    Recall Number
    Z-1012-2007
    Event Number
    38220
    FEI Number
    3005747797
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2007
    Posted
    July 17, 2007
    Terminated
    March 14, 2008
    Address
    4024 Stirrup Creek Dr, Teleflex Creek Dr, Durham, NC, 27703-9000

    Description

    Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G

    Reason

    The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

    Action

    Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.

    Distribution

    Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany

    Quantity

    1920 units total for all types of sutures