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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0351-2017

TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047

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 71324038 Serial Numbers: 13LM19426, 13LM19431, 14BM10263, 14BM10264 REF NUMBER 71324039 Serial Numbers: 13LM16207, 14AM08786, 14AM08786A REF NUMBER 71324040 Serial Numbers: 13LM12963, 13LM17120, 13MM18005, 14BM00728, 14BM10265A, 14BM16804, 13LM12964, 13MM18000, 14AM02711, 14BM00729, 14BM10266, 14BM16815, 13LM16210, 13MM18001, 14AM12034, 14BM01149, 14BM10266A, 13LM17118, 13MM18003, 14BM00727, 14BM10265, 14BM10268 REF NUMBER 71324041 Serial Numbers: 13LM12870, 13LM12880, 13MM18006, 14AM02713, 14AM12043, 14BM20733, 13LM12874, 13LM17121, 14AM02712, 14AM02714, 14BM00730 REF NUMBER 71324042 Serial Numbers: 13LM14881, 13MM02907, 13MM09996, 14BM00737, 14BM06960, 14BM16819A, 13LM14881A, 13MM02907A, 13MM09998, 14BM01141, 14BM06961, 14BM16820, 13LM14883, 13MM02908, 13MM09998A, 14BM01144, 14BM14307, 14BM16822, 13LM14883A, 13MM02909, 14AM12035, 14BM03060, 14BM14318, 14BM16825, 13LM14885, 13MM02910, 14AM12042, 14BM03110, 14BM16819 REF NUMBER 71324043 Serial Numbers: 13LM17122, 13LM19387, 13MM04114, 13MM04124, 13MM08123, 14AM12038, 13LM17123, 13LM19387A, 13MM04116, 13MM04126, 13MM08124, 14AM12038A, 13LM17123A, 13LM19389, 13MM04117, 13MM04126A, 13MM08124A, 14BM00775, 13LM17124, 13MM04108, 13MM04118, 13MM08116, 13MM08126, 14BM00775A, 13LM17125, 13MM04108A, 13MM04120, 13MM08116A, 13MM09999, 14BM01146, 13LM17126, 13MM04111, 13MM04123, 13MM08118, 13MM10001, 13LM19386, 13MM04112, 13MM04123A, 13MM08121, 14AM07555 REF NUMBER 71324044 Serial Numbers: 13KM22764, 13LM00822, 13LM00828, 13LM00831, 13LM00899, 13LM00900, 13LM06362, 13LM06363, 13LM06364, 13LM17127, 13LM17128, 13LM17128A, 13LM17129, 13LM17132, 13LM17133, 13LM17134, 13LM17136, 13LM17157, 13LM17160, 13MM04130, 13MM04130A, 13MM04132, 13MM04132A, 13MM04134, 13MM04135, 13MM04136, 13MM04139, 13MM04139A, 13MM04141, 13MM10009, 14AM15528, 14AM15529, 14AM21699, 14AM21701, 14AM21704, 14AM21707, 14AM24082, 14AM24083, 14AM24084, 14AM24084A, 14AM24085, 14AM24086, 14AM24087, 14AM24088, 14AM24091, 14AM24098, 14BM04004, 14BM04014, 14BM04015, 14BM04017, 14BM04019, 14BM04021, 14BM06965, 14BM06966, 14BM06967, 14BM06970, 14BM06971, 14BM06973, 14BM06975, 14BM06975A, 14BM06977, 14BM06977A, 14BM08966, 14BM08970, 14BM08971, 14BM12189, 14BM12192, 14BM12194, 14BM12195, 14BM14321, 14BM14805, 14DM11275 REF NUMBER 71324045 Serial Numbers: 13KM24095, 13KM24095A, 13KM24097, 13KM24099, 13LM04114, 13LM06366, 13LM17165, 13LM17169, 13LM17169A, 13MM04143, 14AM00467, 14AM00469, 14AM00474, 14AM00478, 14AM00485, 14AM00485A, 14AM00490, 14AM00490A, 14AM02715, 14AM02716, 14AM02717, 14AM02717A, 14AM02718, 14AM02718A, 14AM12041, 14AM16532, 14AM24089, 14AM24090, 14BM03989, 14BM13827, 14BM17706, 14BM17710, 14BM17712, 14BM17712A, 14BM17713 REF NUMBER 71324046 Serial Numbers: 13KM24091, 13LM15742, 13MM13862, 14AM02708A, 14AM24102A, 14BM04026, 13KM24092, 13LM15743, 13MM13863, 14AM02709, 14AM24103, 14BM14323, 13KM24093, 13LM15743A, 13MM13864, 14AM16514, 14AM24103A, 14BM14324, 13LM04070, 13LM15745, 13MM13865, 14AM16514A, 14AM24108, 14BM14324A, 13LM04072, 13LM15745A, 13MM13866, 14AM16515, 14AM24109, 14BM14327, 13LM04073, 13LM15746, 13MM13867, 14AM16520, 14BM00835, 14BM19649, 13LM11741, 13LM15747, 14AM02704, 14AM16521, 14BM01154, 14BM20553, 13LM11741A, 13MM13857, 14AM02705, 14AM16522, 14BM01157, 13LM15736, 13MM13858, 14AM02706, 14AM16524, 14BM04024, 13LM15741, 13MM13859, 14AM02707, 14AM24101, 14BM04024A, 13LM15741A, 13MM13860, 14AM02708, 14AM24102, 14BM04025 REF NUMBER 71324047 Serial Numbers: 13LM00813, 13LM14897, 13MM14128, 14AM00453, 14AM16528, 14BM14334, 13LM01891, 13LM14899, 13MM14134, 14AM16526, 14BM14332, 13LM01892, 13MM13677, 13MM18008, 14AM16526A, 14BM14333, 13LM14895, 13MM14126, 13MM18008A, 14AM16526B, 14BM14333A REF NUMBER 71324048 Serial Numbers: 13LM01893, 13LM14908, 13MM13695A, 14AM00586B, 14AM16531, 14BM08987, 13LM01894, 13LM14909, 14AM00527, 14AM12010, 14BM03036, 14BM08988, 13LM01895, 13LM14910, 14AM00532, 14AM12012,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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