BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

    Recall: Z-0595-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0595-2020
    Event ID
    84224
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 11, 2019
    Initiation Date
    October 25, 2019
    Classification Date
    December 3, 2019
    Termination Date
    April 30, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

    Reason

    Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

    Code Info

    Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670

    Distribution

    Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand

    Quantity

    34 units