BEUDAMED
    FDA Enforcement Class II Terminated

    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611

    Recall: Z-0671-2022 · Reported March 2, 2022

    Enforcement

    Recall Number
    Z-0671-2022
    Event ID
    89544
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 2, 2022
    Initiation Date
    January 7, 2022
    Classification Date
    February 24, 2022
    Termination Date
    April 13, 2023
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611

    Reason

    The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

    Code Info

    Lot Number: 821170 UDI: (01)00880304554122(17) 280825(10)821170

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.

    Quantity

    10 units