BEUDAMED
    FDA Enforcement Class II Ongoing

    Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780

    Recall: Z-0197-2023 · Reported November 16, 2022

    Enforcement

    Recall Number
    Z-0197-2023
    Event ID
    91005
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beaver Visitec International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 16, 2022
    Initiation Date
    September 30, 2022
    Classification Date
    November 7, 2022
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780

    Reason

    Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery

    Code Info

    UDI# 00886158001249 LOT#'s: 6034831,6039837

    Distribution

    FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom

    Quantity

    150 units US; 1116 units OUS