BEUDAMED
    FDA Recall Terminated

    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053

    Recall: Z-2543-2017 · Initiated May 3, 2017

    Recall

    Recall Number
    Z-2543-2017
    Event Number
    77144
    Firm
    Medtronic
    FEI Number
    1219930
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 3, 2017
    Terminated
    July 18, 2019
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053

    Reason

    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

    Action

    All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.

    Distribution

    Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

    Quantity

    478,465 (total for all products)