BEUDAMED
    FDA Enforcement Class II Ongoing

    Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN

    Recall: Z-1678-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1678-2022
    Event ID
    90738
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    September 14, 2022
    Initiation Date
    June 29, 2022
    Classification Date
    September 6, 2022
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN

    Reason

    Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time

    Code Info

    UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B

    Distribution

    US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia

    Quantity

    640 units