Persona

  • Model / Serial
    Part Numbers: 42517400410, 42517400510, 42517400610, 42517400710, 42517400810, 42517400910, 42517401010, 42517401110, 42527400410, 42527400510, 42527400610, 42527400710, 42527400810, 42527400910, 42527401010, and 42527401110. Lot numbers:62043556, 62110045, 62121489, 62125589, 62147235, 62165546, 62168383, 62177247, 62311021, 62314722, 62386421, 62442838, 62525491, 62558585, 62605208, 62627292, 62683432, 62696865, 62717343, 62022344, 62041351, 62073566, 62104372, 62117744, 62121488, 62149175, 62187324, 62187325, 62247351, 62311022, 62314723, 62364961, 62391117, 62436468, 62474903, 62538403, 62564311, 62611089, 62669905, 62690895, 62720225, 62742767, 62747707, 62020946, 62028233, 62073570, 62110047, 62130976, 62187327, 62187329, 62189325, 62290822, 62305407, 62314724, 62386424, 62420258, 62469459, 62531662, 62551356, 62565041, 62584447, 62612266, 62687089, 62690049, 62690909, 62702763, 62724739, 62022345, 62024978, 62104374, 62124040, 62134006, 62200223, 62200224, 62233921, 62294595, 62314725, 62385328, 62436479, 62511942, 62544381, 62565042, 62597795, 62669933, 62696869, 62710618, 62736059, 62768447, 62043559, 62104415, 62121530, 62203396, 62203397, 62314728, 62314730, 62356529, 62390841, 62442847, 62511926, 62551396, 62565057, 62595859, 62654933, 62656069, 62720226, 62034569, 62055683, 62113088, 62130978, 62149714, 62165547, 62168384, 62177253, 62184260, 62256284, 62256285, 62397161, 62420223, 62511956, 62551402, 62565108, 62601570, 62696376, 62742762, 62756031, 62043561, 62055684, 62116593, 62145793, 62152728, 62166195, 62166196, 62168385, 62184261, 62239294, 62319851, 62320878, 62356546, 62390865, 62474905, 62538415, 62565044, 62581863, 62622558, 62632819, 62740693, 62398035, 62440437, 62515479, 62515499, 62563803, 62581853, 62675491, 62059520, 62079725, 62113046, 62144799, 62188423, 62188424, 62188425, 62290837, 62386431, 62436425, 62544361, 62564334, 62601567, 62669897, 62703452, 62742764, 62745001, 62059521, 62064136, 62079726, 62087046, 62104427, 62147239, 62189345, 62189346, 62189347, 62290841, 62351309, 62386782, 62442789, 62469458, 62525501, 62565090, 62565091, 62584448, 62595856, 62656017, 62689230, 62695893, 62710607, 62067441, 62104432, 62130980, 62177257, 62196631, 62196634, 62196637, 62315142, 62315143, 62386432, 62391240, 62442839, 62538411, 62564342, 62581858, 62624335, 62656070, 62686197, 62690916, 62695894, 62710620, 62059522, 62083318, 62104437, 62144801, 62156320, 62161539, 62162598, 62177259, 62239307, 62305411, 62391118, 62469434, 62544379, 62565031, 62595852, 62646287, 62686191, 62686296, 62709061, 62710631, 62746199, 62059523, 62104441, 62145794, 62152729, 62193852, 62193853, 62193854, 62290762, 62356651, 62386783, 62474908, 62531663, 62581867, 62601565, 62632632, 62663173, 62696858, 62697499, 62703451, 62759777, 62055688, 62104442, 62138319, 62187332, 62192904, 62192905, 62201541, 62290838, 62386784, 62436477, 62474904, 62531660, 62565036, 62581860, 62630286, 62658515, 62736051, 62751903, 62059524, 62062241, 62104443, 62138320, 62158149, 62158150, 62162599, 62177261, 62239308, 62255875, 62442842, 62511934, 62551335, 62564347, 62564351, 62624333, 62669906, 62696854, 62696855, 62732175, 62398036, 62440436, 62516039, 62563805, 62648144, and 62704599.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

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    Model: Item number: 42-5099-004-00, Affected: Revision 7 and below
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    Model: Selected part numbers (48 items), Affected: All lots
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