BEUDAMED
    FDA Enforcement Class II Terminated

    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.

    Recall: Z-1115-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1115-2013
    Event ID
    64810
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synvasive Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    April 2, 2013
    Classification Date
    April 15, 2013
    Termination Date
    July 15, 2014
    Address
    4925 Robert J Mathews Pkwy, N/A, El Dorado Hills, CA, 95762-5701, United States

    Description

    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.

    Reason

    Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.

    Code Info

    Lots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647

    Distribution

    Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.

    Quantity

    3442 units per the part numbers listed