BEUDAMED
    FDA Enforcement Class II Terminated

    ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.

    Recall: Z-1363-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1363-2015
    Event ID
    70667
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    February 26, 2015
    Classification Date
    April 1, 2015
    Termination Date
    January 12, 2016
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.

    Reason

    The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.

    Code Info

    PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530

    Distribution

    Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.

    Quantity

    50 Units of each