Retiro De Equipo (Recall) de AFFIXUS Hip Fracture Nail

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zimmer Biomet, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    77221
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2215-2017
  • Fecha de inicio del evento
    2017-04-17
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Nail not properly engaging with the targeting jig due to certain undersized specification.
  • Acción
    On 4/17/2017,  URGENT MEDICAL DEVICE RECALL REMOVAL  Lot Specific notifications were sent to the affected consignees via traceable methods. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Device

  • Modelo / Serial
    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H DLLCTJ DLLCTK DLLCTL DLLCTM DLLCTN DLLCTP DLLCTR DLLCTT DLLCTV DLLCTW DLLCTY DLLCTZ DLMB1M DLMB90 DLMB91 DLMB9J DLMB9K DLMB9L DLMB9M DLMB9N DLMB9P DLMB9R DLMB9T DLMB9V DLMB9W DLMB9Y DLMB9Z DLMBBB DLMBKR DLMBY3 DLMBY4 DLMBY5 DLMBY6 DLMBY7 DLMBY8 DLMBY9 DLMBZ DLMBZ0 DLMBZ1 DLMBZ2 DLMBZ3 DLMBZ4 DLMBZB DLMBZC DLMBZD DLMBZF DLMBZG DLMBZH DLMBZJ DLMBZK DLMBZL DLMBZM DLMBZN DLMBZP DLMBZR DLMBZT DLMBZV DLMBZW DLMBZY DLMBZZ DLMC13 DLMCF0 DLMCF1 DLMCF2 DLMCF3 DLMCF5 DLMCF6 DLMCF7 DLMCF8 DLMCF9 DLMCFP DLMCFR DLMCFT DLMCFV DLMCFW DLMCFY DLMCFZ DLMCGB DLMCGC DLMCGD DLMCGF DLMCGG DLMCGK DLMCGL DLMCGM DLMCGN DLMCGP DLMCGR DLMCGT DLMCGV DLMCGW DLMCGY DLMCK DLNB79 DLNB80 DLNB81 DLNB82 DLNB83 DLNB84 DLNB85 DLNB86 DLNB87 DLNB88 DLNB89 DLNB8B DLNB8C DLNB8D DLNB8F DLNB8G DLNB8H DLNB8J DLNB8K DLNB8L DLNB8M DLNB8N DLNB8P DLNB8R DLNB8T DLNB8V DLNB8W DLNB8Y DLNB8Z DLNB9B DLNB9C DLNB9D DLNB9F DLNB9G DLNB9H DLNB9J DLNB9K DLNB9L DLNB9M DLNBPN DLNBZZ DLPB23 DLPB24 DLPB25 DLPB26 DLPB27 DLPB28 DLPB29 DLPB32 DLPB33 DLPB3B DLPB3C DLPB3D DLPB3F DLPB3G DLPB3H DLPB3J DLPB3K DLPB3L DLPB3M DLPB3N DLPB3P DLPB3R DLPB3T DLPB3V DLPB3W DLPB3Y DLPB3Z DLPB40 DLPB4C DLPB4F DLPB4H DLPB4M DLPB4R DLPB4T DLPB4W DLPB4Y DLPBF0 DLPBF1 DLPBF2 DLPBF3 DLPBF4 DLPBF5 DLPBF6 DLPBF7 DLPBF8 DLPBF9 DLPBFY DLPBFZ DLPBG0 DLPBG1 DLPBG2 DLPBGB DLPBGC DLPBGD DLPBGF DLPBGG DLPBGH DLPBGJ DLPBGK DLPBGL DLPBGM DLPBGN DLPBGP DLPBGR DLPBGT DLPBGV DLPBGW DLPBGY DLPBGZ DLPBT0 DLPBT1 DLPBT2 DLPBT3 DLPBT4 DLPBT5 DLPBT5 DLPBT6 DLPBT7 DLPBT8 DLPBT9 DLPBTW DLPBTY DLPBTZ DLPBVB DLPBVC DLPBVD DLPBVD DLPBVF DLPBVG DLPBVH DLPBVJ DLPBVK DLPBVL DLPBVM DLPBVN DLPBVP DLPBVR DLPBVT DLPBVV DLPBVW DLPBVY DLPCFT DLPCFV DLPCFW DLPCFY DMBB DMBB DMBB00 DMBB0B DMBB0C DMBB0D DMBB0F DMBB0G DMBB0H DMBB0K DMBB0L DMBB0N DMBB0P DMBB0R DMBB0W DMBB0Y DMBB0Z DMBB31 DMBB45 DMBB46 DMBB47 DMBB48 DMBB49 DMBB5B DMBB5C DMBB5D DMBB5F DMBB5G DMBB5H DMBB5J DMBB5K DMBBC0 DMBBC1 DMBBC2 DMBBC3 DMBBC4 DMBBC5 DMBBC6 DMBBC7 DMBBC8 DMBBC9 DMBBCZ DMBBDB DMBBDC DMBBDD DMBBDF DMBBDG DMBBDH DMBBDJ DMBBDK DMBBDL DMBBDR DMBBDT DMBBF0 DMBBF1 DMBBF2 DMBBF3 DMBBF4 DMBBF5 DMBBF6 DMBBF7 DMBBF8 DMBBF9 DMBBFD DMBBFF DMBBFG DMBBFH DMBBFJ DMBBFK DMBBFL DMBBFM DMBBFN DMBBFP DMBBFR DMBBFT DMBBFV DMBBFW DMBBFY DMBBFZ DMBBG DMBBG0 DMBBG1 DMBBG2 DMBBG3 DMBBG4 DMBBG5 DMBBG6 DMBBG7 DMBBG8 DMBBG9 DMBBGB DMBBGC DMBBGD DMBBGF DMBBGG DMBBGH DMBBGJ DMBBGK DMBBGL DMBBGL DMBBGM DMBBGN DMBBGP DMBBGR DMBBGT DMBBGV DMBBGW DMBBGY DMBBGZ DMBBH DMBBH0 DMBBH1 DMBBH2 DMBBH3 DMBBH4 DMBBH5 DMBBH6 DMBBH7 DMBBHB DMBBHC DMBBHD DMBBHF DMBBHG DMBBHH DMBBHJ DMBBHK DMBBHL DMBBHM DMBBHN DMBBHP DMBBHR DMBBHT DMBBHV DMBBHW DMBBHY DMBBHZ DMBBY6 DMBBY7 DMBBY8 DMBBY9 DMBBZ0 DMBBZ1 DMBBZ2 DMBBZ3 DMBBZ4 DMBBZ5 DMBBZ6 DMBBZ7 DMBBZ8 DMBBZ9 DMBBZB DMBBZC DMBBZD DMBBZF DMBBZG DMBBZH DMBBZJ DMBBZK DMBBZL DMBBZM DMBBZN DMBBZP DMBBZR DMBBZT DMBBZV DMBBZW DMBBZY DMBBZZ DMBCF0 DMBCF1 DMBCF2 DMBCF3 DMBCF4 DMBCF5 DMBCF6 DMBCF8 DMBCF9 DMBCFC DMBCFD DMBCFF DMBCFG DMBCFH DMBCFJ DMBCFK DMBCFL DMBCFM DMBCFN DMBCFP DMBCFR DMBCFT DMBCFV DMBCFW DMBCFY DMBCFZ DMBCGB DMBCGC DMBCGD DMBCGF DMBCGG DMBCGH DMBCGJ DMBCGK DMBCGL DMBTT DMCB DMCB DMCB10 DMCB11 DMCB12 DMCB13 DMCB14 DMCB15 DMCB16 DMCB17 DMCB18 DMCB19 DMCB1P DMCB1R DMCB1T DMCB1V DMCB1W DMCB1Y DMCB1Z DMCB2 DMCB20 DMCB22 DMCB23 DMCB24 DMCB25 DMCB26 DMCB27 DMCB28 DMCB29 DMCB2B DMCB2C DMCB2D DMCB2F DMCB2G DMCB2H DMCB2J DMCB2K DMCB2L DMCB2M DMCB2N DMCB2P DMCB2R DMCB2T DMCB2V DMCB2W DMCB2Y DMCB2Z DMCB30 DMCB31 DMCB32 DMCB33 DMCB34 DMCB35 DMCB3B DMCB3C DMCB3D DMCB3F DMCB3G DMCB3H DMCB3J DMCB3K DMCB3L DMCB3M DMCB3N DMCB3P DMCB3R DMCB3T DMCB3V DMCB3W DMCB3Y DMCB3Z DMCBB5 DMCBB6 DMCBB7 DMCBB8 DMCBB9 DMCBCB DMCBCC DMCBCD DMCBCF DMCBCG DMCBCH DMCBCJ DMCBCK DMCBCL DMCBCM DMCBCN DMCBCP DMCBCR DMCBCT DMCBG0 DMCBG1 DMCBG2 DMCBG3 DMCBG4 DMCBG5 DMCBG6 DMCBG7 DMCBG8 DMCBGD DMCBGF DMCBGG DMCBGH DMCBGJ DMCBGK DMCBGL DMCBGN DMCBGP DMCBGR DMCBGT DMCBGV DMCBGW DMCBGY DMCBGZ DMCBH0 DMCBH1 DMCBH2 DMCBH3 DMCBH4 DMCBH5 DMCBH6 DMCBH7 DMCBH8 DMCBH9 DMCBHB DMCBHC DMCBHD DMCBHF DMCBHG DMCBHH DMCBHJ DMCBHK DMCBHL DMCBHM DMCBHN DMCBHP DMCBHR DMCBHT DMCBHV DMCBHW DMCBHY DMCBHZ DMCBJ0 DMCBJ1 DMCBJ2 DMCBJ3 DMCBJ4 DMCBJ5 DMCBJ6 DMCBJ7 DMCBJ8 DMCBJ8 DMCBJ9 DMCBJB DMCBJC DMCBJD DMCBJF DMCBJG DMCBJH DMCBJJ DMCBJK DMCBJL DMCBJM DMCBJN DMCBJP DMCBJR DMCBJT DMCBJV DMCBJW DMCBJY DMCBKB DMCBKC DMCBKD DMCBKF DMCBKG DMCBKH DMCBKJ DMCBKK DMCBKL DMCBKM DMCBKN DMCBKN DMCBKP DMCBKR DMCBKT DMCBKV DMCCD8 DMCCD8 DMCCD9 DMCCF DMCCF0 DMCCF1 DMCCF2 DMCCF3 DMCCF4 DMCCF5 DMCCF6 DMCCF7 DMCCF8 DMCCF9 DMCCFB DMCCFC DMCCFD DMCCFF DMCCFG DMCCFH DMCCFJ DMCCFK DMCCFL DMCCFM DMCCFN DMCCFP DMCCFR DMCCFT DMCCFV DMCCFW DMCCFY DMCCFZ DMCCGB DMCCGC DMCCGD DMCCGF DMCCGF DMCCGG DMCCGH DMCCGJ DMCCGK DMCCGL DMCCGM DMCCGN DMCCGP DMCCGR DMCCGT DMCCGV DMCCGW DMDB09 DMDB10 DMDB11 DMDB12 DMDB13 DMDB14 DMDB15 DMDB16 DMDB17 DMDB18 DMDB19 DMDB1B DMDB1C DMDB1D DMDB1F DMDB1G DMDB1H DMDB1J DMDB1K DMDB1L DMDB1M DMDB1N DMDB1P DMDB1R DMDB1T DMDB1V DMDB1W DMDB1Y DMDB1Z DMDB20 DMDB21 DMDB22 DMDB23 DMDB24 DMDB25 DMDB26 DMDB27 DMDB28 DMDB2B DMDB2C DMDB2D DMDB2F DMDB2G DMDB2H DMDB2J DMDB2K DMDB2L DMDB2M DMDB2N DMDB2P DMDB2R DMDB2T DMDB2V DMDB2W DMDB2Y DMDB2Z DMDB35 DMDB3B DMDB3C DMDB3D DMDB3D DMDB3F DMDB3G DMDB3H DMDB3J DMDB3K DMDBC DMDBC0 DMDBC1 DMDBC2 DMDBC3 DMDBC4 DMDBC5 DMDBC6 DMDBCH DMDBCJ DMDBCK DMDBCL DMDBCM DMDBCN DMDBCP DMDBCR DMDBCT DMDBCV DMDBCW DMDBCY DMDBCZ DMDBDC DMDBF1 DMDBF2 DMDBF3 DMDBF4 DMDBF5 DMDBFJ DMDBFK DMDBFL DMDBFM DMDBFN DMDBFR DMDBFT DMDBFV DMDBFW DMDBFY DMDBFZ DMDBP8 DMDBP9 DMDBPJ DMDBR0 DMDBR1 DMDBR2 DMDBR3 DMDBR4 DMDBR5 DMDBR6 DMDBR7 DMDBR8 DMDBR9 DMDBRB DMDBRC DMDBRD DMDBRF DMDBRG DMDBRH DMDBRJ DMDBRK DMDBRL DMDBRM DMDBRN DMDBRP DMDBRR DMDBRT DMDBRV DMDBRW DMDBRY DMDBRZ DMDBT0 DMDBT1 DMDBT2 DMDBT3 DMDBTB DMDBTC DMDBTC DMDBTD DMDBTF DMDBTG DMDBTH DMDBTJ DMDBTK DMDBTL DMDBTM DMDBTN DMDBTO DMDBTP DMDBTR DMDBTT DMDBTV DMDBTW DMDBTY DMDBTZ DMDCB4 DMDCB5 DMDCB6 DMDCB7 DMDCB9 DMDCCB DMDCCC DMDCCD DMDCCF DMDCCG DMDCCH DMDCCJ DMDCCK DMDCCL DMDCCM DMDCCN DMDCCP DMDCCR DMDCCT DMDCCV DMDCCW DMDCF9 DMDCG0 DMDCG2 DMDCG4 DMDCG5 DMDCG6 DMDCG8 DMDCG9 DMDCGB DMDCGC DMDCGD DMDCGF DMDCGG DMDCGH DMDCGK DMDCGL DMDCGP DMDCGR DMDCGT DMDCGV DMDCGY DMDCHB DMDCHC DMDCHD DMDCHF DMDCHG DMDCHH DMDCHJ DMDCHK DMDCHL DMDCHM DMDCMF DMDD8 DMDD80 DMDD81 DMDD82 DMDD83 DMDD84 DMDD85 DMDD86 DMDD88 DMDD89 DMDD8D DMDD8F DMDD8H DMDD8J DMDD8K DMDD8L DMDD8M DMDD8N DMDD8P DMDD8R DMDD8T DMDD8V DMDD8W DMDD8Y DMDD8Z DMDD9B DMDD9C DMDD9D DMDD9F DMDD9G DMDD9H DMFB70 DMFB71 DMFB72 DMFB73 DMFB74 DMFB75 DMFB76 DMFB77 DMFB78 DMFB79 DMFB7Y DMFB7Z DMFB80 DMFB81 DMFB82 DMFB8B DMFB8C DMFB8D DMFB8F DMFB8G DMFB8H DMFB8J DMFB8K DMFB8K DMFB8L DMFB8M DMFB8N DMFB8P DMFB8R DMFB8T DMFB8W DMFB8Y DMFB8Z DMFBBB DMFBH0 DMFBH2 DMFBH3 DMFBH4 DMFBH5 DMFBH6 DMFBH7 DMFBH8 DMFBH9 DMFBHP DMFBHR DMFBHT DMFBHV DMFBHW DMFBHY DMFBHZ DMFBJB DMFBJC DMFBJD DMFBJF DMFBJG DMFBJH DMFBJJ DMFBJK DMFBJL DMFBJM DMFBJN DMFBJP DMFBJR DMFC DMFC0B DMFCH0 DMFCH1 DMFCH2 DMFCH3 DMFCH4 DMFCH5 DMFCH6 DMFCH6 DMFCH8 DMFCHR DMFCHT DMFCHV DMFCHW DMFCHY DMFCHZ DMFCJ1 DMFCJ2 DMFCJB DMFCJC DMFCJD DMFCJG DMFCJJ DMFCJK DMFCJL DMFCJM DMFCJN DMFCJP DMFCJR DMFCJT DMFCJV DMFCJW DMFCJY DMFCYJ DMFCYK DMFCYM DMFCYN DMFCYP DMFCZ0 DMFCZ1 DMFCZ2 DMFCZ3 DMFCZ4 DMFCZ5 DMFCZ6 DMFCZ7 DMFCZ8 DMFCZ9 DMFCZR DMFCZT DMFCZV DMFCZW DMFCZZ DMFD80 DMG DMGB40 DMGB41 DMGB42 DMGB43 DMGB44 DMGB45 DMGB46 DMGB47 DMGB48 DMGB49 DMGB4V DMGB4W DMGB4Y DMGB4Z DMGB50 DMGB51 DMGB52 DMGB53 DMGB5B DMGB5G DMGB5H DMGB5J DMGB5K DMGB5L DMGB5M DMGB5N DMGB5P DMGB5R DMGB5T DMGB5V DMGB5W DMGB5Y DMGB5Z DMGBP4 DMGBP5 DMGBP6 DMGBP7 DMGBP8 DMGBP9 DMGBR DMGBR1 DMGBR3 DMGBR4 DMGBR5 DMGBR6 DMGBR8 DMGBRB DMGBRD DMGBRF DMGBRG DMGBRH DMGBRJ DMGBRK DMGBRM DMGBRN DMGBRV DMGBRW DMGBRZ DMGBTB DMGBTC DMGBTD DMGBTG DMGBTJ DMGBTL DMGBTP DMGBTT DMGBTW DMGBTY DMGBTZ DMGC4 DMGC40 DMGC41 DMGC42 DMGC43 DMGC44 DMGC45 DMGC46 DMGC47 DMGC48 DMGC49 DMGC4Y DMGC4Z DMGC5C DMGC5D DMGC5F DMGC5G DMGC5H DMGC5J DMGC5K DMGCFG DMGCFJ DMGCFK DMGCFL DMGCFM DMGCFN DMGCFP DMGCFT DMGCFV DMGCFW DMGCFY DMGCFZ DMGCG0 DMGCG2 DMGCG4 DMGCG5 DMGCGB DMGCGC DMGCGD DMGCGG DMGCGJ DMGCGK DMGCGL DMGCGN DMGCGP DMGCGT DMGCGW DMGCGZ DMGCHJ DMGCW0 DMGCW1 DMGCW2 DMGCW3 DMGCW4 DMGCW4 DMGCW5 DMGCW6 DMGCW7 DMGCW8 DMGCW9 DMGCWG DMGCWH DMGCWJ DMGCWK DMGCWL DMGCWM DMGCWN DMGCWP DMGCWR DMGCWT DMGCWV DMGCWW DMGCWY DMGCWZ DMGCY DMGCYB DMGCYC DMGCYD DMGCYF DMGCYG DMGCYH DMGCYJ DMGCYK DMGCYL DMGCYM DMGCYN DMGCYP DMGCYR DMGCYT DMGCYV DMGCYW DMHB3 DMHB30 DMHB31 DMHB32 DMHB33 DMHB34 DMHB35 DMHB36 DMHB37 DMHB38 DMHB39 DMHB4B DMHB4F DMHB4G DMHB4R DMHB4T DMHB52 DMHB98 DMHB99 DMHBBR DMHBHV DMHBHW DMHBHY DMHBHZ DMHBJ0 DMHBJ1 DMHBJ2 DMHBJ3 DMHBJ4 DMHBJ5 DMHBJ6 DMHBJH DMHBJK DMHBJL DMHBJM DMHBJN DMHBJP DMHBJR DMHBJT DMHBJW DMHBJZ DMHCBB DMHCBC DMHCBD DMHCBF DMHCBG DMHCBH DMHCBJ DMHCBK DMHCP0 DMHCP1 DMHCP1 DMHCP2 DMHCP3 DMHCP5 DMHCP6 DMHCPH DMHCPJ DMHCPM DMHCPP DMHCPR DMHCPT DMHCPV DMHCPW DMHCPY DMHCPZ DMJBJ0 DMJBJ1 DMJBJ2 DMJBJ3 DMJBJ7 DMJBJ8 DMJBJ9 DMJBJW DMJBJY DMJBJZ DMJBK0 DMJBK1 DMJBK2 DMJBK3 DMJBK4 DMJBK5 DMJBKB DMJBKC DMJBKD DMJBKF DMJBKG DMJBKH DMJBKJ DMJBKK DMJBKM DMJBKM DMJBKN DMJBKP DMJBKR DMJBKT DMJBKV DMJBKW DMJBKY DMJBKZ DMJBWK DMJBY0 DMJBY1 DMJBY2 DMJBY3 DMJBY4 DMJBY5 DMJBY6 DMJBY7 DMJBY8 DMJBY9 DMJBYN DMJBYO DMJBYP DMJBYR DMJBYT DMJBYV DMJBYY DMJBYZ DMJBZB DMJBZC DMJBZD DMKB9V DMKBL0 DMKBL1 DMKBL2 DMKBL3 DMKBL4 DMKBL5 DMKBLP DMKBLR DMKBLT DMKBLV DMKBLW DMKBLY DMKBLZ DMKCZP DMKCZR DMLBK7 DMLBK8 DMLBK9 DMLBLB DMLBLD DMLBLF DMLBLH DMLBLJ DMLC47 DMLC48 DMLC49 DMLC5B DMLC5C DMLC5D DMLC5F DMLC5H DMLCYK DMLCYL DMMBFT DMMBFV DMMBFW DMMCB5 DMMCB6 DMNBR1 DMNBR3 DMNBR6 DMNBR7 DMNBY5 DMNBY7 DMNBY8 DMNBY9 DMNBZB DMNCB0 DMNCB1 DMNCBM DMNCBN DMNCBP DMNCBR DMNCBT DMNCBV DMNCBW DMNCBY DMNCBZ DMNCP4 DMNCP5 DMNCP6 DMNCP7 DMNCP8 DMNCP9 DMNCR3 DMNCR4 DMPB0T DMPB0V DMPBGH DMPBGJ DMPBGK DMPBGM DMPBGN DMPBGR DMPBGT DMPBGV DMPBGW DMPBGY DMPBJD DMPBJF DMPBJG DMPBJH DMPBJJ DMPBJK DMPBJL DMPBJM DMPBOV DN DNBB0C DNBB0D DNBB0F DNBB0G DNBB0H DNBB0J DNBB5N DNBB7J DNBB7K DNBB7L DNBB7M DNBB7N DNBB7P DNBB7R DNBB7V DNBB7W DNBB7Y DNBB7Z DNBBDM DNBBDN DNBBDP DNBBDR DNBBGB DNBBGC DNBBGD DNBBGF DNBBGG DNBBGH DNBBGJ DNBBT5 DNBBT6 DNBBT7 DNBBZ6 DNBBZ7 DNBBZ8 DNBCF0 DNBCF1 DNBCF2 DNBCF4 DNBCF5 DNBCF6 DNBCFP DNBCFR DNBCFT DNBCFV DNBCFW DNBCFY DNBCFZ DNCB0B DNCB53 DNCB54 DNCB55 DNCB56 DNCB58 DNCB59 DNCB60 DNCB61 DNCB62 DNCB64 DNCB6B DNCB6C DNCB6D DNCB6F DNCB6H DNCB6J DNCB6K DNCB6L DNCB6M DNCB6N DNCB6P DNCB6R DNCB6T DNCB6V DNCB6Y DNCB6Z DNCBF9 DNCBJ1 DNCBJ2 DNCBJ2 DNCBJ3 DNCBJ4 DNCBJ5 DNCBJ6 DNCBJ7 DNCBJ8 DNCBJ9 DNCBJM DNCBJN DNCBJP DNCBJR DNCBJT DNCBJV DNCBJW DNCBKB DNCBZ DNCBZ2 DNCBZ3 DNCBZ8 DNCBZ9 DNCBZD DNCBZG DNCBZH DNCBZJ DNCBZK DNCBZL DNCBZM DNCBZN DNCBZP DNCBZR DNCBZT DNCBZV DNCBZW DNCBZY DNCCK8 DNDB7 DNDB70 DNDB71 DNDB72 DNDB73 DNDB74 DNDB74 DNDB75 DNDB76 DNDB77 DNDB7N DNDB7P DNDB7R DNDB7Y DNDB7Z DNDBHL DNDBHN DNDBHR DNDBHW DNDBJ0 DNDBJ1 DNDBJ2 DNDBJ3 DNDBJ4 DNDBJN DNDBJP DNDBJR DNDBJT DNDBJV DNDBJW DNDBJY DNDBJZ DNDBK4 DNDBK5 DNDBK6 DNDBK7 DNDBK8 DNDBK9 DNDBLB DNDBLC DNDC44 DNDC45 DNDC47 DNDC48 DNDC49 DNDC5B DNDC5C DNDC5D DNDC5F DNDC5G DNDC5H DNDCK1 DNDCK2 DNDCK4 DNDCK6 DNDCK7 DNDCK8 DNDCK9 DNDCKV DNDCL0 DNDCL1 DNDCL2 DNDCL3 DNDCL4 DNDCL5 DNDCL6 DNDCL7 DNDCL8 DNDCLB DNDCLD DNDCLG DNDCLH DNDCLK DNDCLZ DNDCMC DNDCMD DNFBD3 DNFBD5 DNFBN0 DNFBN1 DNFBN2 DNFBNT DNFBNV DNFBNW DNFBNY DNFBNZ DNFBYB DNFBYC DNFBYD DNFBYF DNFBYG DNFBYH DNFCH0 DNFCHO DNFCHP DNFCHR DNFCHT DNFCHV DNFCHW DNFCHY DNFCHZ DNGBCB DNGBCD DNGBCF DNGBCG DNGBLP DNGBLR DNGBLT DNGBLT DNGBLV DNGBV8 DNGBY6 DNGBY7 DNGBY8 DNGBY9 DNGBZB DNGBZC DNGBZD DNGBZG DNGC6K DNGCY0 DNGCY1 DNGCY2 DNGCY3 DNGCY4 DNGCYN DNGCYP DNGCYR DNGCYT DNGCYV DNGCYW DNGCYY DNGCYZ DNGDD0 DNGDD1 DNGDD2 DNGDD3 DNGDD4 DNGDDY DNGDDZ DNHB5 DNHB51 DNHB52 DNHB53 DNHB54 DNHB55 DNHB56 DNHB57 DNHB58 DNHB59 DNHBRK DNHBRL DNHBRR DNHBRW DNHBRY DNHBRZ DNHC51 DNHC52 DNHC52 DNHC53 DNHC54 DNHC55 DNHC56 DNHC57 DNHC59 DNHC59 DNHC5L DNHC5M DNHC5N DNHC5P DNHC5R DNHC5T DNHC5V DNHC5W DNHC5Y DNHC5Z DNHC6B DNHC6C DNHC6D DNHC6F DNHC6G DNHC6H DNHC6Y DNHCL DNHCL0 DNHCL1 DNHCLN DNHCLP DNHCLR DNHCLT DNHCLV DNHDNC DNHDNH DNKB9 DNKB90 DNKB91 DNKB92 DNKB93 DNKB9K DNKB9L DNKB9M DNKB9N DNKB9P DNKB9T DNKB9V DNKB9W DNKB9Y DNKB9Z DNKBC0 DNKBC1 DNKBC2 DNKBCR DNKBCT DNKBCV DNKBCW DNKBCY DNKBCZ DNKBG DNKBGK DNKBGL DNKBGM DNKBGN DNKBGP DNKBGR DNKBGT DNKBGV DNKBGW DNKBGY DNKBGZ DNKBL2 DNKBL3 DNKBL4 DNKBL5 DNKBL7 DNKBL8 DNKBL9 DNKBMB DNKBMC DNKBMD DNKBMF DNKBMG DNKBMH DNKBMJ DNKBMK DNKBML DNKBMM DNKBMN DNKBMP DNKBMR DNKBMT DNKBMV DNKCN3 DNKCN4 DNKCN5 DNKCN6 DNKCN7 DNKCN8 DNKCN9 DNKCPB DNKCPC DNKCPD DNKCPF DNLB2C DNLB2D DNLB2F DNLB2G DNLB2H DNLB2J DNLB2K DNLB2L DNLB2M DNLB2N DNLB2P DNLB2R DNLB2T DNLB2V DNLBML DNLBMM DNLBMN DNLBMP DNLBMR DNLBMT DNLBMV DNLBMW DNLBMY DNLBTG DNLBTH DNLBTJ DNLBTK DNLBTL DNLBTM DNLBTN DNLBTP DNLBTR DNLC5 DNLC51 DNLC52 DNLC53 DNLC54 DNLC55 DNLC56 DNLC57 DNLC58 DNLC59 DNLC6B DNLC6C DNLC6D DNLC6F DNLC6G DNLC6H DNLC6J DNLC6K DNLC6L DNLCRH DNLCRJ DNLCT0 DNLCT1 DNLCT2 DNLCT3 DNLCT4 DNLCT5 DNLCT6 DNLCT7 DNLCT9 DNLCTM DNLCTN DNLCTP DNLCTR DNLCTT DNLCTV DNLCTW DNLCTY DNLCTZ DNLCVB DNMB2J DNMB2K DNMB2L DNMB2M DNMB2N DNMB2P DNMB2W DNMB2Y DNMBN6 DNMBN7 DNMBN8 DNMBN9 DNMBPB DNMBPC DNMBPD DNMBPF DNMBPG DNMBPH DNMBPJ DNMC40 DNMC41 DNMC42 DNMC43 DNMC44 DNMC46 DNMC48 DNMC4Y DNMC4Z DNMC5B DNMCF0 DNMCF1 DNMCF2 DNMCFR DNMCFW DNMCFY DNMCG4 DNMCG7 DNMCGD DNMCGF DNMCGJ DNMCGK DNMCGL DNMCGM DNMCGN DNMCGP DNMCGR DNMCGT DNMDJ0 DNMDJ1 DNMDJ2 DNMDJ3 DNMDJ4 DNMDJ5 DNMDJ6 DNMDJ7 DNMDJ8 DNMDJ9 DNMDJN DNMDJP DNMDJR DNMDJT DNMDJV DNMDJW DNMDJY DNMDJZ DNMDKB DNMDKC DNMDKF DNMDKG DNMDKH DNMDKJ DNMDKK DNMDKM DNNB85 DNNB87 DNNB88 DNNB9B DNNB9D DNNB9F DNNB9G DNNB9H DNNB9J DNNB9K DNNB9M DNNB9N DNNB9P DNNB9R DNNB9Y DNNB9Z DNNBBC DNNBBD DNNBCJ DNNBG0 DNNBG1 DNNBG2 DNNBG3 DNNBG4 DNNBG5 DNNBG6 DNNBG7 DNNBG8 DNNBGP DNNBGR DNNBGT DNNBGV DNNBGY DNNBHB DNNBHC DNNBHD DNNBHG DNNBHH DNNBHK DNNBHL DNNBLC DNNC4W DNNC55 DNNC5P DNNC5V DNNC5W DNNC64 DNNC65 DNNC68 DNNC69 DNNC6T DNNC6W DNNC6Y DNNC8W DNNCKZ DNNCM0 DNNCM1 DNNCM2 DNNCM3 DNNCM4 DNNCM5 DNNCMB DNNCMF DNNCMH DNNCMJ DNNCMK DNNCML DNNCMM DNNCMR DNNCMT DNNCMV DNNCMW DNNCMY DNNCMZ DNPB20 DNPB21 DNPB23 DNPB24 DNPB25 DNPB26 DNPB27 DNPB28 DNPB2Y DNPB3B DNPB3H DNPB3L DNPB3M DNPB3N DNPB3P DNPB3R DNPB3T DNPBL0 DNPBL7 DNPBL9 DNPBLF DNPBLJ DNPBLK DNPBLL DNPBLM DNPBLP DNPBLR DNPBLT DNPBLW DNPBLY DNPBLZ DNPBMC DNPBMG DNPBMR DNPBMT DNPBMV DNPBMW DNPBMY DNPBMZ DPBB6R DPBB6V DPBB6W DPBB6Y DPBB6Z DPBB9B DPBB9F DPBBF4 DPBBF5 DPBBF6 DPBBF8 DPBBF9 DPBBGB DPBBGC DPBBGD DPBBGF DPBBGH DPBBGJ DPBBGK DPBBGL DPBBGM DPBBGN DPBBGR DPBBGV DPBBGW DPBBGZ DPBBV9 DPBBW0 DPBBW1 DPBBWB DPBBWC DPBBWD DPBBWG DPBBWH DPBBWJ DPBBWK DPBBWL DPBBWM DPBBWP DPBBWR DPBBWT DPBBWZ DPBCBD DPBCBJ DPBCC2 DPBCC3 DPBCC4 DPBCC5 DPBCC6 DPBCC7 DPBCC8 DPBCC9 DPBCCJ DPBCCP DPBCCT DPBCCV DPBCCW DPBCN1 DPBCNH DPBCNJ DPBCNK DPBCNL DPBCNM DPBCNN DPBCNP DPBCNR DPBCNT DPBCNW DPBCNY DPBCNZ DPBCPB DPBCPC DPBCPD DPBCPF DPBCPJ DPBCPL DPBCPM DPCB00 DPCB01 DPCB02 DPCB03 DPCB04 DPCB05 DPCB06 DPCB07 DPCB09 DPCB0W DPCB0Z DPCB1B DPCB1C DPCB1F DPCB1G DPCB1J DPCB1K DPCB1L DPCB1M DPCB20 DPCB21 DPCB6V DPCBH0 DPCBH1 DPCBH2 DPCBH3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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, COLOMBIA, COSTA RICA, NETHERLANDS, JAPAN, SPAIN AND CANARY ISLANDS, SWITZERLAND and UNITED KINGDOM.
  • Descripción del producto
    AFFIXUS Hip Fracture Nail || Product Usage: || The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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