BEUDAMED
    FDA Enforcement Class II Terminated

    Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015

    Recall: Z-1536-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1536-2018
    Event ID
    79700
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    December 11, 2017
    Classification Date
    April 26, 2018
    Termination Date
    September 21, 2020
    Address
    130 & 120 Forbes Blvd, N/A, Mansfield, MA, 02048, United States

    Description

    Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015

    Reason

    Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.

    Code Info

    Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355

    Distribution

    Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.

    Quantity

    22