BEUDAMED
    FDA Enforcement Class II Terminated

    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.

    Recall: Z-2576-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2576-2014
    Event ID
    68878
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    August 7, 2014
    Classification Date
    September 4, 2014
    Termination Date
    January 27, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.

    Reason

    Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.

    Code Info

    Part Numbers: 42517600410, 42517600510, 42517600610, 42517600710, 42517600810, 42517600910, 42517601010, 42517601110, 42527600410, 42527600510, 42527600610, 42527600710, 42527600810, 42527600910, 42527601010, and 42527601110. Lot numbers: 62342526, 62423918, 62423919, 62423920, 62427414, 62482212, 62563745, 62612225, 62656072, 62740698, 62342527, 62405895, 62430401, 62504179, 62511925, 62563784, 62638665, 62695870, 62343066, 62406967, 62432146, 62515486, 62564324, 62691390, 62717335, 62351291, 62374838, 62415307, 62430397, 62518138, 62622527, 62696875, 62357867, 62374796, 62427836, 62441229, 62511924, 62563908, 62565948, 62590523, 62695295, 62361315, 62376662, 62420192, 62434748, 62518137, 62540059, 62563778, 62627131, 62698733, 62363684, 62367078, 62423914, 62430398, 62494662, 62565936, 62658602, 62695876, 62445930, 62340579, 62344051, 62423923, 62423924, 62423925, 62423926, 62482213, 62563747, 62610937, 62710619, 62342528, 62405897, 62434390, 62515483, 62563726, 62612227, 62695297, 62349892, 62422726, 62434393, 62515488, 62563788, 62631075, 62698741, 62355455, 62374809, 62421505, 62434752, 62522772, 62602612, 62695290, 62717336, 62368460, 62374671, 62415303, 62435709, 62435710, 62435711, 62505567, 62563909, 62565944, 62691386, 62360467, 62374806, 62422729, 62434754, 62504020, 62630275, 62691388, 62698735, 62368463, 62374824, 62423915, 62435712, 62435713, 62499165, 62563927, 62565963, 62446275, and 62502226.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.

    Quantity

    77,737 units total