BEUDAMED
    FDA Enforcement Class II Terminated

    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

    Recall: Z-0964-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0964-2015
    Event ID
    70042
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mentor Texas, LP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    December 11, 2014
    Classification Date
    January 13, 2015
    Termination Date
    January 4, 2016
    Address
    3041 Skyway Cir N, Irving, TX, 75038-3500, United States

    Description

    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

    Reason

    The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

    Code Info

    6790747-030, 6684051-002, 6685063-013, 6728126-044, 6822437-031, 6685063-011, 6728128-035, 6702298-031, 6838011-018, 6733863-003, 6733863-017, 6701421-023, 6696938-022, 6824389-004, 6719893-016, 6687714-031, 6834854-016, 6839585-001, 6849927-019, 6675404-028, 6684051-031, 6803156-029, 6838011-020, 6825406-014, 6751554-012, 6741590-026, 6830995-006, 6721250-014, 6694754-031, 6707932-006, 6789276-002, 6790619-029, 6821980-010, 6853040-025, 6691833-020, 6715539-004, 6836766-012, 6683549-030, 6703183-005, 6789532-021, 6789191-001, 6848592-012, 6790747-028, 6833028-030, 6723961-006, 6716622-011, 6742458-008, 6684051-026, 6685067-008, 6703784-036, 6748082-029, 6748820-019, 6822436-028, 6827017-004, 6829287-016, 6834856-021, 6825200-001, 6701421-034, 6716223-011, 6794993-017, 6723958-007, 6723958-011, 6723957-042.

    Distribution

    US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA

    Quantity

    45 units