BEUDAMED
    FDA Enforcement Class II Terminated

    SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    Recall: Z-0576-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0576-2013
    Event ID
    63545
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    December 3, 2012
    Classification Date
    December 20, 2012
    Termination Date
    November 13, 2013
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    Reason

    An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

    Code Info

    Product Code: 157215165 and Lot codes: 111621, FG9KT1, 126365, X3VB41000, A19GL1000, X4SC51000, A3XF31000, X4SC5A000, A3XF3A000, X4SC61000, A63GR1000, X53B11000, A6AE81000, X5REA1000, A6AE8A000, YF4AX1000, AY7KN1000, YF4AXA000, AY7KNA000, YG2CY1000, B19CJ1000, Z41AT1000, B3BJV1000, Z6BB91000, B3CAX1000, Z83BA1000, B65DF1000, Z83BAB000, B65DFA000, ZL9FW1000, C1YLX1000, ZL9FWA000, C34B81000, C34B8A000, C4JCR1000, C4JCRA000, C4VCR1000, C4VCRA000, CB2K71000, CH7ED1000, CK3EX1000, D32J61000, D46LG1000, D6DDD1000, D88H81000, DA2EN1000, DD3BS1000, DD3BSA000, DG1PA1000, DS7KC1000, E1KJ91000, E3SDG1000, E56BX1000, E5EB31000, FB3E31, FB8P91, FE9P41, and FG9KS1.

    Distribution

    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

    Quantity

    1732 total all product codes