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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1422-2024

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; 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 320-42-00, UDI/DI 10885862086693, Serial Numbers: 0982062, 1064609, 1093925, 1000132, 1000124, 1064624, 1000137, 1064629, 1064643, 1064639, 1093902, 1064617, 1093913, 1093909, 1093905, 1000121, 1000115, 1064610, 0982056, 1000123, 0982059, 1000128, 0982053, 0982073, 0982064, 0982066, 0982076, 0982063, 0982071, 0982065, 1064636, 0982074, 1064642, 0982075, 1000136, 1000135, 1000131, 1093931, 1000130, 0982070, 1000117, 1000113, 1064634, 1000129, 1064623, 1093910, 1000116, 0982055, 1064594, 1064600, 1064614, 1064638, 1064641, 1000126, 1000122, 0982058, 1064633, 1093912, 1093939, 1093907, 1093922, 1093923, 1093928, 1093929, 1100342, 1064611, 1093918, 1100320, 1100347, 1100359, 1064602, 1064640, 1064606, 1064631, 1064607, 1064604, 1100357, 1100361, 1100317, 1093924, 1100349, 1100327, 1000114, 1064625, 1100345, 1100353, 1000125, 1064598, 1093908, 1064632, 1064612, 1064595, 1000138, 1093919, 1000119, 1000120, 1064596, 1100331, 1100336, 1064635, 1093935, 1100324, 1064622, 1093901, 1100323, 0982068, 0982061, 1100341, 1100334, 1064627, 1100363, 1093917, 1100322, 1100364, 0982060, 1064613, 1064608, 1100346, 1064621, 1093911, 0982052, 1093920, 1100329, 1100365, 1100328, 1064603, 1064616, 1093934, 1100360, 1100355, 1100366, 1100326, 1100344, 1064597, 1100335, 0982072, 1064630, 1064593, 1064618, 1093921, 1100337, 1100338, 1093914, 1100358, 1100348, 1100362, 1100319, 1100321, 1100330, 1093916, 1100332, 1100354, 1000134, 1093930, 1093927, 1290049, 1216151, 1358417, 1216160, 1216119, 1216208, 1216205, 1216183, 1216189, 1290022, 1290006, 1289971, 1365488, 1290020, 1216125, 1365487, 1216194, 1216130, 1216106, 1290058, 1365459, 1358383, 1216177, 1289977, 1358410, 1216128, 1358425, 1216105, 1216140, 1216116, 1216108, 1216182, 1216173, 1290025, 1216132, 1216193, 1290029, 1290059, 1216120, 1216136, 1365468, 1289973, 1216188, 1289964, 1216186, 1216190, 1216152, 1289968, 1216143, 1216201, 1216170, 1216104, 1290007, 1216133, 1216175, 1216204, 1290026, 1216157, 1216169, 1358413, 1216192, 1216185, 1216155, 1216198, 1290056, 1216115, 1216181, 1216167, 1290027, 1216146, 1216162, 1289990, 1290053, 1290054, 1216114, 1216144, 1216141, 1289982, 1358418, 1290008, 1290034, 1216118, 1216110, 1216111, 1216122, 1216124, 1216129, 1216159, 1216165, 1216166, 1216107, 1216134, 1216135, 1216164, 1216206, 1216168, 1216171, 1216176, 1216179, 1216149, 1289996, 1289965, 1289980, 1289988, 1289993, 1289999, 1290001, 1290002, 1290003, 1290011, 1290023, 1290024, 1290031, 1290033, 1290041, 1290043, 1290045, 1290047, 1290050, 1290051, 1290052, 1216203, 1093926, 1100325, 1064637, 1093903, 1100333, 1100340, 1100316, 1100343, 1093938, 1064619, 1064599, 1064626, 1093933, 1064628, 0982054, 1100356, 1064615, 1100339, 1528611, 1216163, 1358377, 1365497, 1216138, 1216154, 1289966, 1438100, 1358385, 1430227, 1358395, 1430270, 1482896, 1430220, 1216156, 1528610, 1430234, 1365499, 1289995, 1545563, 1358382, 1552360, 1459738, 1358407, 1358396, 1552324, 1290004, 1438090, 1430282, 1445734, 1445728, 1552337, 1358372, 1365480, 1290017, 1438104, 1482876, 1358398, 1482898, 1528612, 1482892, 1476773, 1459728, 1482880, 1476772, 1289983, 1365486, 1365470, 1358391, 1482908, 1358401, 1459737, 1482890, 1358420, 1358406, 1290021, 1430278, 1365458, 1438089, 1459744, 1482909, 1482887, 1438101, 1552340, 1476780, 1216102, 1445732, 1290005, 1358423, 1290016, 1545573, 1365495, 1430202, 1216158, 1216202, 1365496, 1552339, 1476788, 1365461, 1438108, 1365489, 1482895, 1459734, 1535735, 1358393, 1290000, 1290044, 1290012, 1216195, 1358381, 1358380, 1365464, 1365456, 1552341, 1430222, 1430221, 1216126, 1365482, 1289978, 1535738, 1430276, 1438097, 1289969, 1535746, 1535749, 1430243, 1358419, 1482873, 1290032, 1482891, 1290042, 1438102, 1365500, 1482882, 1365492, 1482883, 1545564, 1545562, 1528615, 1535748, 1545575, 1289987, 1430275, 1528614, 1358411, 1365473, 1365502, 1430246, 1430250, 1358388, 1358374, 1289985, 1430271, 1365475, 1289998, 1365460, 1289984, 1290028, 1358424, 1438093, 1445729, 1438105, 1
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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