FDAFDA · Alimentos y medicamentos·N.º oficial Z-1417-2024
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
Publicado el 10 de abril de 2024 · Inicio del retiro: 6 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Exactech, Inc.
- Distribuidor
- Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
- Lote
- a) Item Number 320-36-10, UDI/DI 10885862086631, Serial Numbers: 2608259, 2878175, 3759662, 3759663, 3810144, 3810149, 3786337, 3872525, 3872529, 3872524, 3872528, 3872526, 3872520, 3872535, 3872523, 3872539, 3872521, 3872534, 3872533, 3872537, 3872522, 2608258, 3872538, 3872536, 4124979, 4124982, 4124983, 4124978, 4291229, 4291226, 2878177, 4291213, 4124977, 4291230, 5027717, 3786334, 3872527, 4888837, 4888833, 5027713, 4988489, 4988487, 5027718, 4888828, 5165724, 5165727, 5165729, 4291218, 4291227, 3872531, 4291221, 4291228, 4291234, 4291225, 4291220, 5027706, 5027712, 5165730, 4696503, 4794697, 4696499, 4794698, 5165725, 4794699, 5869637, 5874634, 5869433, 5874635, 5869631, 5874638, 5869472, 5874626, 5909270, 5869429, 5869638, 5869450, 6167632, 5909268, 5869418, 5869422, 5909261, 5909266, 4291209, 4291231, 4794696, 5165722, 4988486, 4888836, 5869629, 6105291, 5869630, 6167625, 6023991, 6167650, 5869439, 6167646, 6522758, 6167637, 6190136, 6105269, 5869425, 6105281, 6064916, 6049281, 6167628, 6167644, 6190164, 6411847, 6190200, 6190139, 6049285, 6064914, 6008302, 5869475, 6044055, 6064921, 6064918, 6190229, 6167627, 6167652, 6190176, 6044060, 6190216, 5909259, 6105292, 6190171, 6522745, 5874639, 6553343, 6553295, 6593394, 6418061, 4988494, 4988493, 5869463, 6522759, 6008270, 6008278, 6522764, 6167648, 6167653, 6167630, 6044056, 5869443, 6008301, 6190135, 6008265, 6064908, 6008276, 5869437, 6483972, 6522742, 6167643, 6167611, 6008287, 6522768, 6023885, 6483986, 6008291, 6411835, 5869420, 5869459, 5869444, 6483966, 6190166, 6023973, 6167642, 6008283, 6190219, 6522770, 6105276, 5869438, 5869417, 6522731, 6190224, 6522761, 6023984, 6105289, 6190168, 5909267, 6008258, 6190198, 6190162, 6484020, 6394867, 6394854, 6167615, 6522744, 6064928, 6008290, 6190163, 6522779, 6167655, 6522736, 6008300, 6008256, 6023894, 6190126, 6049286, 6105267, 6044053, 6064915, 6064905, 6483973, 6105294, 6008284, 6522771, 5869435, 6008310, 5874636, 5874617, 6167612, 6418069, 6553339, 6418077, 6418072, 6713228, 6553334, 6418059, 6593370, 6553333, 6567052, 6713255, 6553293, 6593369, 6713249, 6713194, 6713221, 6593399, 5165721, 4988492, 5027709, 4988488, 6411842, 6190175, 6023902, 6483950, 6167620, 5869428, 6483951, 6483984, 6484005, 6044057, 6008296, 6411833, 6049283, 6167657, 6483976, 6190145, 6064912, 5869454, 6105266, 5874610, 6105280, 6483959, 6483991, 5869453, 6023981, 6484006, 6105295, 6483982, 6394881, 5869639, 6023890, 6394883, 5874615, 6044063, 6167641, 5869452, 6023982, 6023889, 6044064, 6483971, 6411843, 6008308, 6008279, 6167619, 6484007, 6394869, 6190227, 6190124, 6411846, 6064923, 6483983, 6008257, 5909260, 5909274, 6008269, 6023887, 6105265, 6190230, 6008294, 6190209, 6064920, 6064906, 6023972, 6105287, 6167636, 6008299, 6008251, 6522777, 6008262, 6167618, 6190161, 6023983, 6064910, 6023886, 6049288, 6394878, 6190148, 6190228, 6418064, 6713252, 6713211, 6713251, 6713239, 6713207, 6593443, 6418066, 6553342, 6713209, 6418060, 6553321, 6713210, 6713219, 6713232, 6593430, 6593368, 6593393, 6593415, 6553288, 6593387, 6593450, 6593439, 6418056, 6553344, 6567042, 6567053, 6553311, 6713227, 6713222, 6593423, 6713248, 6713244, 6567027, 6593410, 6593385, 6167614, 6023988, 6411841, 6394874, 5874618, 5869462, 6105282, 6190137, 6484000, 6483981, 6190220, 6394876, 6008280, 6483953, 6522739, 5869440, 6190150, 6008263, 6008254, 6023893, 6008289, 5869446, 6190199, 6484010, 6190214, 6044062, 6064929, 6484016, 6483980, 6105286, 6190206, 6190218, 6190194, 5869632, 6008306, 6008309, 5869423, 6484009, 6023979, 6411837, 6190128, 6167645, 6522737, 6394865, 6008271, 6008307, 6484017, 6049287, 6190179, 5869432, 6190207, 6190191, 6190195, 6008268, 5909258, 6049282, 6522773, 6484015, 6190203, 6522786, 6483998, 5909277, 6713203, 6418067, 6567060, 6567044, 6553318, 6567037, 6713193, 6593447, 6553325, 6593432, 6593438, 6593383, 6593377, 6713218, 6553303, 6593431, 6593451, 6418071, 6713215, 6713235, 6567047, 6713229, 6553291, 6593375, 6713240, 6418076, 6064932, 6190133, 6
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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