BEUDAMED
    FDA Enforcement Class II Terminated

    BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    Recall: Z-1960-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1960-2016
    Event ID
    74084
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    April 22, 2016
    Classification Date
    June 14, 2016
    Termination Date
    October 13, 2017
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945, United States

    Description

    BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    Reason

    Potential for polystyrene particulate presence.

    Code Info

    Catalog #: AR-8948W-1665; Batch #: 10020489; Unique Device Identifier: 00888867202726.

    Distribution

    Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.

    Quantity

    138 total products