BEUDAMED
    FDA Enforcement Class II Terminated

    LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.

    Recall: Z-1949-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1949-2016
    Event ID
    74082
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    May 2, 2016
    Classification Date
    June 10, 2016
    Termination Date
    December 9, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States

    Description

    LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.

    Reason

    Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.

    Code Info

    Lot Number 9890811, Catalog ID 02.110.115S

    Distribution

    Distributed to one customer: Colorado

    Quantity

    6 units