BEUDAMED
    FDA Recall 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 · Initiated February 26, 2015

    Recall

    Recall Number
    Z-1363-2015
    Event Number
    70667
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDR
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 26, 2015
    Posted
    April 2, 2015
    Terminated
    January 12, 2016
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.

    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