FDAFDA · Alimentos y medicamentos·N.º oficial Z-2034-2014
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. 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: 00771100410, Lot #: 60876583, 61098988, 61158127, 61230791, 61542496, 61548105, 61702995, 61729254, 61904645, 61957233, 61963047, 61998392, 62004467, 62067479, 62078278, 62096889, 62107667, 62145541, 62153634, 62184289, 62246880, 62246881, 62253651, 62265027, 62283066, 62316369, 62343031, 62356431, 62361531, 62380986, 62390746, 62445410, 62459360, 62472165, 62495527, 62528301, 62529331, 62529334, 62529335, 62529341, 62577926, 62577929 & 62630007. Product ID: 00771100440, Lot #: 60500974, 60597171, 60824961, 61040634, 61510553, 61601757, 61703092, 61796656, 61870553, 61880423, 61904646, 61963030, 61967702, 62101479, 62135089, 62153635, 62158616, 62176234, 62179221, 62202469, 62239214, 62253653, 62253654, 62275332, 62275333, 62302332, 62309445, 62316374, 62342712, 62405371, 62410988, 62472168, 62521896, 62554173, 62571801, 62577931, 62601210 & 62645212. Product ID: 00771100510, Lot #: 61098989, 61158128, 61595675, 61734799, 61791458, 61870554, 61919455, 61967734, 61985992, 62023864, 62059114, 62085023, 62135094, 62135095, 62143027, 62145548, 62145549, 62145551, 62169649, 62198214, 62238349, 62243359, 62243360, 62302339, 62302341, 62342714, 62367890, 62445414, 62458976, 62459363, 62509237, 62529278, 62529353, 62529362, 62537985, 62540589 & 62554177. Product ID: 00771100540, Lot #: 60659250, 61030264, 61085549, 61098994, 61595699, 61690452, 61749176, 61765962, 61796657, 61845539, 61865602, 61966525, 62004475, 62078283, 62096893, 62130151, 62143029, 62153639, 62158620, 62207884, 62258663, 62271060, 62275338, 62323507, 62335521, 62335522, 62361538, 62445416, 62452735, 62489955, 62503202, 62540593, 62594190 & 62615704. Product ID: 00771100610, Lot #: 61030252, 61416334, 61523437, 61894915, 61894916, 61966499, 62085032, 62114298, 62158626, 62207887, 62219914, 62226003, 62236540, 62238352, 62243369, 62243372, 62243373, 62275343, 62289018, 62302344, 62309453, 62335525, 62356440, 62379097, 62393282, 62405381, 62409688, 62410998, 62411003, 62423064, 62423065, 62445419, 62452741, 62478872, 62478874, 62488298, 62503204, 62528348, 62528349, 62529374, 62529375, 62529377, 62529379, 62550187, 62560161, 62577945, 62615711, 62659356 & 62665753. Product ID: 00771100640, Lot #: 60474089, 60663859, 60911091, 61158157, 61553126, 61631840, 61741531, 61851980, 61860883, 61966531, 62023869, 62059125, 62143033, 62153641, 62187415, 62198221, 62219917, 62219918, 62246894, 62246895, 62265031, 62274956, 62275347, 62343049, 62379098, 62393285, 62405385, 62445421, 62503207, 62521909, 62571810 & 62615713. Product ID: 00771100710, Lot #: 60771280, 61273016, 61499266, 61734803, 61784581, 61812353, 61851927, 62014580, 62053391, 62078295, 62118155, 62141440, 62158635, 62201777, 62231894, 62231895, 62231898, 62243374, 62243375, 62243378, 62275356, 62282228, 62295531, 62302353, 62309465, 62335540, 62343056, 62367904, 62370016, 62381004, 62381005, 62393291, 62400759, 62405394, 62411014, 62416694, 62423075, 62452751, 62458992, 62458994, 62472190, 62488317, 62488318, 62509254, 62509255, 62528381, 62529406, 62537934, 62540614, 62547061, 62547063, 62560179, 62615729, 62645241, 62659370, 62665772, 62681694 & 62681696. Product ID: 00771100740, Lot #: 61550135, 61631841, 61734866, 61772718, 61801919, 61972446, 62023879, 62023881, 62096907, 62135115, 62141445, 62184314, 62198237, 62207901, 62226018, 62231906, 62236548, 62253676, 62289036, 62289037, 62295537, 62309552, 62329235, 62335546, 62343068, 62381009, 62381010, 62393296, 62411019, 62416699, 62416703, 62423083, 62433065, 62433067, 62450644, 62484310, 62488330, 62496123, 62503221, 62540619, 62548499, 62586864, 62594206, 62615732, 62645247, 62645248, 62653028 & 62665780. Product ID: 00771100910, Lot #: 61487760, 61734804, 61851922, 61919486, 61930771, 62004532, 62028813, 62085052, 62114319, 62191514, 62231919, 62243388, 62249182, 62265046, 62295542, 62295546, 62302368, 62316429, 62343075, 62350653, 62350654, 62370035, 62381023, 62405415, 62411029, 62423093, 62433074, 62438948, 62457810,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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