BEUDAMED
    FDA Enforcement Class II Ongoing

    Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.

    Recall: Z-2897-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2897-2018
    Event ID
    80583
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Richard Wolf GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    July 24, 2017
    Classification Date
    August 22, 2018
    Address
    Pforzheimer Str. 32, Knittlingen, N/A, Germany

    Description

    Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.

    Reason

    Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

    Code Info

    Product Number 89140.0105, Lot Number 4500197481

    Distribution

    Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.

    Quantity

    12 units