BEUDAMED
    FDA Enforcement Class II 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 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2543-2017
    Event ID
    77144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    May 3, 2017
    Classification Date
    June 14, 2017
    Termination Date
    July 18, 2019
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    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.

    Code Info

    ENDO STITCH* POLYSORB* 0 48" U/D DLU SU J4M0853X J4M0855X J5A0192X ENDO STITCH* POLYSORB* 0 48" VIO DLU SU J4L1477X ENDO STITCH*POLYSORB* 2/0 48" U/D DLU SU J5A1097X ENDO STITCH*POLYSORB* 2/0 48" VIO DLU SU J5A0702X J5A0703X J5A0704X J5A0705X J5A1206X J5A1207X

    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)