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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2579-2014

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.

Publicado el 10 de septiembre de 2014 · Inicio del retiro: 7 de agosto de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Zimmer, Inc.
Distribuidor
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.
Lote
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.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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