FDAFDA · Alimentos y medicamentos·N.º oficial Z-0350-2017
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
Publicado el 9 de noviembre de 2016 · Inicio del retiro: 29 de agosto de 2016
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
Some Bipolar shells were manufactured with an out of specification retainer groove.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Smith & Nephew, Inc.
- Distribuidor
- Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates
- Lote
- REF NUMBER 71322040 Serial Numbers: 14AM13511, 14AM13511A REF NUMBER 71322041 Serial Numbers: 14AM21654 REF NUMBER 71322042 Serial Numbers: 13LM06353, 13MM17938, 13MM17940, 14AM01852, 14AM04660, 14AM04662, 13LM06354, 13MM17939 REF NUMBER 71322043 Serial Numbers: 13KM21801, 13LM09191, 13MM09504, 14AM01946, 14AM04663, 14BM15318, 13LM06356, 13LM09204, 13MM09507, 14AM02029, 14AM21664, 14BM15318A, 13LM06356A, 13MM02843, 14AM01855, 14AM02046, 14BM01137, 14BM19345 REF NUMBER 71322044 Serial Numbers: 13KM21825, 13LM09225, 13MM09510, 14AM02112, 14AM04670, 14BM08940A, 13KM24083, 13LM09236, 13MM09517, 14AM02118, 14AM13546, 13KM24083A, 13LM09236A, 13MM09517A, 14AM02120, 14BM01133, 13KM24084, 13MM02853, 13MM09517B, 14AM02120A, 14BM01133A, 13LM06357, 13MM02857, 13MM14125, 14AM04667, 14BM08938, 13LM06361, 13MM02857A, 13MM14135, 14AM04668, 14BM08940 REF NUMBER 71322045 Serial Numbers: 13KM17382, 13KM24087, 13MM02862A, 13MM17942, 14AM04672, 14BM08950, 13KM21826, 13LM00819, 13MM09520, 13MM17943, 14AM13549, 14BM08958, 13KM22753, 13LM09243, 13MM09520A, 13MM17943A, 14AM21666, 14BM15339, 13KM22755, 13LM09247, 13MM09523, 14AM02117, 14AM21669, 13KM24086, 13MM02862, 13MM17941, 14AM02117A, 14BM06955 REF NUMBER 71322046 Serial Numbers: 13KM17387, 13LM09274, 13LM11684, 13MM09524A, 14AM04682, 14BM15355, 13KM22756, 13LM09275, 13MM02888A, 13MM09526, 14AM13552, 14BM15358, 13KM22756A, 13LM09275A, 13MM02892, 13MM09527, 14AM21677, 14BM16787, 13KM24089, 13LM09278, 13MM02893, 13MM09991, 14AM21681, 14BM19253, 13LM00818, 13LM09281, 13MM02893A, 14AM02121, 14BM06952, 13LM00818A, 13LM11683, 13MM02897, 14AM02121A, 14BM12173, 13LM09258, 13LM11683A, 13MM09524, 14AM02124, 14BM12174 REF NUMBER 71322047 Serial Numbers: 13LM00809, 13LM00817B, 13LM11695, 13MM02901, 14AM21693, 14BM16794A, 13LM00809A, 13LM09285A, 13LM11700, 13MM02901B, 14BM12175, 14BM16795, 13LM00810, 13LM09289, 13LM14993, 13MM09528, 14BM12176, 14BM16795A, 13LM00816, 13LM09289A, 13LM15004, 13MM09529, 14BM16791, 13LM00817A, 13LM11689, 13MM02900, 14AM02127, 14BM16794 REF NUMBER 71322048 Serial Numbers: 13LM01881, 13LM01886, 13LM11730, 13MM02905, 14AM13555, 14BM08977, 13LM01882, 13LM11707, 13LM11730A, 13MM09994, 14AM16949, 14BM12177, 13LM01883, 13LM11707A, 13LM11731, 13MM17944, 14AM16951, 13LM01883A, 13LM11709, 13LM14017, 13MM17947, 14BM08976 REF NUMBER 71322049 Serial Numbers: 13LM01887, 13LM01889, 13LM11734, 13MM02906, 13MM13869A, 13MM14122A, 13LM01888, 13LM01890, 13LM14022, 13MM13868, 13MM14119, 14BM12178, 13LM01888A, 13LM11732, 13LM14023, 13MM13869, 13MM14122, 14BM12178A REF NUMBER 71322050 Serial Numbers: 13LM11735, 13LM12855, 13LM15017, 13MM13870, 13MM17994, 13LM12820, 13LM12957, 13LM15751, 13MM13871, 13MM17995, 13LM12852, 13LM12960, 13LM15751A, 13MM13871A, 14BM01122 REF NUMBER 71322051 Serial Numbers: 13LM12961, 13LM12962A, 13LM14032A, 13LM14035, 13MM13872, 14BM16796, 13LM12961A, 13LM14025, 13LM14033, 13LM14037, 13MM13873, 14BM16796A, 13LM12962, 13LM14032, 13LM14034A, 13LM16186, 13MM17997 REF NUMBER 71322052 Serial Numbers: 13LM16191, 14AM02691, 14AM02694, 14AM04689, 14BM12179A, 14BM12182A, 13LM16192, 14AM02691A, 14AM04683, 14AM21695, 14BM12179B, 14BM12182B, 13LM16193, 14AM02692, 14AM04687, 14AM21695A, 14BM12181, 13LM16193A, 14AM02693, 14AM04688, 14BM12179, 14BM12182 REF NUMBER 71322053 Serial Numbers: 13LM16195, 14AM02695, 14AM02697, 14AM16934, 14AM21696, 14BM12183, 13LM16197, 14AM02696, 14AM06639, 14AM16935, 14AM21696A, 14BM12184 REF NUMBER 71322054 Serial Numbers: 13KM22757, 13LM16204, 14AM02699, 14AM02701B, 14AM16936, 14BM12186, 13KM22758, 13LM16204A, 14AM02700, 14AM02702, 14AM16937, 13LM16203, 13MM03205, 14AM02701, 14AM02702A, 14AM16937A, 13LM16203A, 14AM02698, 14AM02701A, 14AM02703, 14BM12185 REF NUMBER 71322055 Serial Numbers: 13LM16205, 14AM02710A, 14AM16940, 14BM01110A, 14BM12187, 14AM02710, 14AM16938, 14BM01110, 14BM01110B REF NUMBER 71322057 Se
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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