BEUDAMED
    FDA Enforcement Class II Terminated

    OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

    Recall: Z-0471-2013 · Reported December 12, 2012

    Enforcement

    Recall Number
    Z-0471-2013
    Event ID
    63612
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    December 12, 2012
    Initiation Date
    November 1, 2012
    Classification Date
    December 4, 2012
    Termination Date
    April 29, 2013
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

    Reason

    Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

    Code Info

    Part Numbers 32-472661 , 8.0 thru 12.5 Lot 013020, 050310, 056280, 154670, 418380, 691220, 755510, 860171, 866460

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.

    Quantity

    46