BEUDAMED
    FDA Enforcement Class II Terminated

    Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.

    Recall: Z-0789-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0789-2016
    Event ID
    73091
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf Medical Instruments Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    November 25, 2015
    Classification Date
    February 9, 2016
    Termination Date
    August 21, 2017
    Address
    353 Corporate Woods Pkwy, N/A, Vernon Hills, IL, 60061-3110, United States

    Description

    Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.

    Reason

    Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.

    Code Info

    Product numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514. Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 4500166254

    Distribution

    Distributed in Washington.

    Quantity

    Ten units