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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2033-2014

Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.

Publicado el 16 de julio de 2014 · Inicio del retiro: 23 de mayo 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

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Zimmer, Inc.
Distribuidor
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Lote
Product ID: 00771100500, Lot #: 60418073, 60814878, 61085493, 61221743, 61576204, 61621459, 61621460, 61801966, 61825644, 61825646, 61851938, 61856660, 61899990, 61909935, 61957246, 61963045, 61967714, 61978787, 62004470, 62071524, 62078280, 62101467, 62143024, 62145543, 62145545, 62179230, 62201751, 62207880, 62213705, 62219904, 62243355, 62309446, 62316375, 62323504, 62329221, 62329222, 62367889, 62386075, 62450636, 62458975, 62472170, 62547040, 62554175, 62564731, 62564732, 62571806, 62615699, 62645213, 62645214, 62652987, 62667687, 77000640 & 77002057. Product ID: 00771100520, Lot #: 7886860, 60371589, 60389984, 60911201, 60993979, 60999893, 61112021, 61585384, 61622518, 61825666, 61825667, 61851924, 61904650, 61951060, 61967705, 62004472, 62004473, 62028785, 62107673, 62130149, 62135097, 62253657, 62253658, 62323506, 62335517, 62410994, 62458977, 62459364, 62472174, 62503201, 62547042, 62564734, 62571808, 62615703, 62636751 & 62636752. Product ID: 00771100600, Lot #: 61067223, 61389192, 61440890, 61613526, 61699183, 61765877, 61772616, 61851919, 61870556, 61919457, 61925455, 61925460, 61978791, 61985997, 61998399, 62004516, 62016452, 62044968, 62125014, 62125015, 62125017, 62145557, 62184296, 62187413, 62213709, 62213710, 62219910, 62219911, 62226002, 62236538, 62323511, 62329225, 62329226, 62380990, 62416655, 62433042, 62459366, 62466091, 62489957, 62489958, 62529364, 62547046, 62554183, 62590697, 62615709, 62645219, 62652995, 62659348 & 77002100. Product ID: 00771100620, Lot #: 7887710, 11006337, 60814885, 60837122, 60876619, 60935819, 61112024, 61304434, 61755954, 61784588, 61904652, 61945405, 61972436, 61998401, 62014575, 62016455, 62130154, 62153643, 62158627, 62201765, 62226004, 62249176, 62253663, 62274955, 62335527, 62356442, 62361541, 62361542, 62416667, 62423066, 62466094, 62489397, 62509251, 62540605, 62564743, 62571809, 62577958, 62586851, 62622688, 62622689 & 62653004. Product ID: 00771100700, Lot #: 61734759, 61837544, 61978805, 62023873, 62059128, 62059132, 62078290, 62096904, 62101438, 62163749, 62169669, 62184307, 62184309, 62201774, 62201775, 62213721, 62226013, 62253668, 62253669, 62282222, 62295527, 62295529, 62302348, 62309461, 62316392, 62316393, 62316394, 62343052, 62350640, 62370012, 62379099, 62380993, 62380998, 62393286, 62393287, 62400751, 62433056, 62478042, 62478043, 62483286, 62484613, 62488308, 62488310, 62488314, 62521917, 62529381, 62540611, 62564748, 62586859, 62608633, 62615717, 62615720, 62630027, 62645229, 62645233, 62653011, 62653012, 62653018 & 62659363. Product ID: 00771100720, Lot #: 60718307, 61329143, 61721071, 61791501, 61904659, 61915121, 61963043, 61978809, 61978811, 61998380, 62004524, 62053392, 62089239, 62089240, 62118159, 62150305, 62163761, 62198235, 62226017, 62231904, 62249178, 62271083, 62282231, 62289028, 62309538, 62316415, 62343058, 62445432, 62540618, 62548498, 62554198, 62571815, 62577960, 62577961, 62601229, 62608641, 62630036 & 62637054. Product ID: 00771100900, Lot #: 61239370, 61690526, 61874323, 61915128, 62004528, 62067023, 62089044, 62089241, 62107690, 62130175, 62135117, 62155221, 62184318, 62198246, 62207908, 62213747, 62213749, 62226020, 62226029, 62243384, 62258677, 62316423, 62323533, 62329246, 62329250, 62329251, 62329252, 62335549, 62350650, 62356461, 62361555, 62370030, 62370033, 62381019, 62386089, 62393301, 62393303, 62438941, 62444848, 62450646, 62452759, 62466109, 62478016, 62488334, 62488335, 62488336, 62489407, 62489414, 62489418, 62521935, 62529418, 62537946, 62547023, 62547026, 62550180, 62560190, 62568620, 62571824, 62571825, 62577965, 62577967, 62577978, 62577980, 62586867, 62590715, 62601238, 62608649, 62608653, 62630041, 62630044, 62636780, 62636785, 62653032, 62653040, 62665781, 62665786, 62665789 & 62667721. Product ID: 00771100920, Lot #: 61253985, 61375619, 61512772, 61585393, 61595710, 61957210, 61998409, 62041869, 62053407, 62067029, 62067030, 62078314, 62096919, 62114320, 62213762, 62226037, 62238364, 62243395, 62
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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