BEUDAMED
    FDA Enforcement Class II Ongoing

    PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

    Recall: Z-1571-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1571-2023
    Event ID
    92084
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 17, 2023
    Initiation Date
    March 31, 2023
    Classification Date
    May 10, 2023
    Address
    1000 Route 202, N/A, Raritan, NJ, 08869-1425, United States

    Description

    PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

    Reason

    Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

    Code Info

    UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH

    Distribution

    International distribution in the countries of United Kingdom, Ireland and Turkey.

    Quantity

    1,656 eaches (OUS only)