Events

Retiro De Equipo (Recall) de Device Recall REFLECTION(R) DEAD BLOW MALLET

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Smith & Nephew, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    75751
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1008-2017
  • Fecha de inicio del evento
    2016-11-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151142
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Causa
    The firm received complaints of cracks in the weld on the head of the mallet. in the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
  • Acción
    Smith and Nephew sent an Urgent - Product Recall 1 st Notification dated November 16, 2016, to all affected customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, please place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 3. Please contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1- 901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment. Actions for Smith & Nephew Affiliates/Distributors 1.Send this letter to your customers and ask them to return the recalled product. 2. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, cease distribution and use of those products, and quarantine them immediately. 3. Complete the last two columns in the Inventory Return Certification Form above, indicating the quantities that need to be returned. If you do not have product to return, please place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 4. Please contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1- 901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 5. Return any affected product

Device

Device Recall REFLECTION(R) DEAD BLOW MALLET
  • Modelo / Serial
    606861, 606862, 606863, 606864, 701432, 701433, 808421, 808422, 1200840, 50903653, 60708545, 60806634, 61005467, 70704991, 70907344, 71002434, 71106654, 71106655, 80603593, 80603594,  80609278, 80610026, 80807064, 81007463, 81108699, 81202445, 90309401, 90309402, 90309937,  90309941, 90309943, 7136210699, 00701432A, 01BM13815, 01BM13816, 01GM03498, 01GM03503, 01GM03504, 01GM03506, 01JM01382, 02DM06721, 02DM06722, 02EM06595, 02FM01963, 2LM00998, 02LM01099, 02LM01100, 02MM02211, 02MM02211A, 03CM01191, 03EM04694, 03HM11994, 03KM13414, 04AM06979, 04BM09860, 04DM13907, 04DM17920, 04DM17921, 04EM07129, 04EM07132, 04GM03326, 04GM03327, 04GM03328, 04GM03329, 04GM03330,  04KM01861, 04KM13683, 04KM13684, 04MM02700, 04MM02701, 05AM14642, 05AM14643, 05AM14644, 05AM14645, 05AM14646, 05AM14646A, 05EM08660, 05EM08661, 05FM07198,  05FM07199, 05GM00620, 05GM00621,05GM00622, 05GM01203, 05GM01204, 05GM01205, 05GM02670, 05GM02671, 05GM05689, 05GM05690, 05GM05692, 05GM08285, 05GM08286,  05GM08287, 05HM03895, 05HM03896, 05HM07787, 05HM07788, 05HM07789, 05HM07790, 05HM07791, 05HM08138, 05HM08139, 05HM08140, 05HM12179, 05HM12180, 05JM02349,  05JM02350, 05LM11363, 05LM11364, 05LM11365, 05MM07114, 05MM07115, 05MM07116, 06AM12304, 05MM07114, 06DM06240, 06FM08915, 07AM04686, 07EM23206, 05MM07115,  06DM08506, 06GM03246, 07AM04687, 07EM23207, 05MM07116, 06DM08507, 06GM03247,  07AM04688, 07EM23207A, 06AM12304, 06DM08508, 06GM04389, 07AM04689, 07EM23208,  06AM12306, 06DM08510, 06GM04390, 07BM11025, 07FM13912, 06AM12307, 06DM08511,  06HM04336, 07BM11027, 07FM22176, 06BM06458, 06DM08513, 06HM04337, 07BM11028,  07FM22177, 06BM06459, 06DM14258, 06HM13309, 07CM20766, 07FM22177R, 06BM06460,  06EM07997, 06HM13310, 07CM20767, 07FM22179, 06DM03707, 06EM07998, 06HM13311,  07CM20769, 07FM22180, 06DM03709, 06EM07999, 06HM13312, 07CM20770, 07FM22180R,  06DM03710, 06EM08000, 06KM05142, 07CM20772, 07FM22181, 06DM04641, 06EM08001,  06KM05143, 07CM20773, 07FM22181R, 06DM04642, 06EM08913, 06KM05144, 07DM20507,  07GM15214 06DM04643, 06EM08914, 06KM09904, 07DM20511, 07JM08242, 06DM04644,  06EM08915, 06KM09905, 07DM20512, 07JM08244, 06DM04645, 06EM08916, 06LM07300,  07DM20513, 07JM08246, 06DM04646, 06EM08917, 06LM07302, 07DM20517, 07JM08248,  06DM06236, 06EM15667, 06MM06711, 07EM17133, 07JM08253, 06DM06237, 06EM15668,  06MM06712, 07EM17134, 07JM08254, 06DM06238, 06EM18051, 07AM04684, 07EM17135,  07JM08254R, 06DM06239, 06FM05947, 07AM04685, 07EM17139, 07JM08256, 07KM02873,  08GM15339, 09EM01236, 10MM09446, 11MM06903, 07KM02875, 08GM15340, 09EM01237, 10MM09448, 12BM07223, 07KM02876, 08GM15341, 09EM01238, 10MM09450, 12BM10723,  07KM02877, 08GM15342, 09EM01239, 11AM08358, 12BM10724, 07KM17062, 08HC08114,  09EYW0009, 11AM08358A, 12BM17244, 07KM17063, 08HM08096, 09EYW0009A, 11AM08359,  12BM17245, 07KM23733, 08HM08100, 09EYW0009B, 11AM08359A, 12BM18966, 07KM23734,  08HM08101, 09EYW0009C, 11AM08360, 12CM17458, 07KM23735, 08HM08104, 09EYW0009D,  11AM08361, 12DM05835, 07LM10125, 08HM08105, 09EYW0009E, 11AM08364, 12DM05835A,  07LM10126, 08HM08106, 09EYW0010, 11AM10562, 12DM05836, 07LM10127, 08HM08107,  09EYW0010A, 11AM10564, 12DM05836A, 07LM10128, 08HM08108, 09EYW0010B, 11AM10566,  12DM10416, 07LM10129, 08HM08109, 07LM13415, 08HM08110, 07LM13416, 08HM08111, 07LM13417, 08HM08113, 07LM13418, 08HM08114, 07LM13419, 08HM08115, 07LM13420, 08HM08116, 07MM13910, 08MM15605, 07MM13911, 08MM15605A, 07MM13911R, 08MM15606, 07MM13912 , 08MM15608, 07MM13912R, 08MM15609, 07MM13914, 08MM15611, 07MM13915, 09AM19274, 07MM13917, 09AM19276, 07MM13917R, 09BM09445, 08AM04897, 09BM09447, 08EM13465, 09BM09449, 08EM19975, 09BM09450, 08FM09824, 09BM15217, 08FM09826, 09BM15219, 08FM09827, 09BM15220, 08FM09829, 09BMI5217, 08FM11005, 09BMI5219, 08FM11006, 09BMI5220, 08FM16340, 09BMO9445, 08FM16341, 09BMO9450, 08FM16342, 09CM18713, 08FM16343, 09CM18715, 08FM16344, 09CM18717, 08FM16345, 09CMI8715, 08GM15336, 09DM13396, 08GM15337, 09DM13399, 08GM15338, 09DM13400, 12KM16514, 12KM16515, 12KM17287, 12LM02029, 12LM02109, 12LM07522, 13BM15733, 13CM12241, 13CM12244, 13DM05887, 13DM05888, 13DM09094, 13DM11253, 13DM19796, 13DM20982, 13DM20982A, 13EM09454, 13EM09455, 13FM02852, 13FM18101, 13FM18102, 13FM18102A, 13GM09614, 13GM09615, 13GM10866, 13GM20305, 13HM01391,13HM04334, 13HM20062, 13JM09524, 08HM08109, 08HM08110, 08HM08111, 08HM08113, 08HM08114, 08HM08115, 08HM08116, 08MM15605, 08MM15605A, 08MM15606, 08MM15608, 08MM15609, 08MM15611, 09AM19274, 09AM19276, 09BM09445, 09BM09447, 09BM09449, 09BM09450, 09BM15217, 09BM15219, 09BM15220, 09BMI5217, 09BMI5219, 09BMI5220, 09BMO9445, 09BMO9450, 09CM18713, 09CM18715, 09CM18717, 09CMI8715, 09DM13396, 09DM13399, 09DM13400, 14BM01667, 14BM01668, 14BM01669, 14BM01670, 14BM01671, 14BM01672, 14BM01673, 14BM04157, 14BM04158, 14BM04159, 14BM04160, 14BM04160R, 14CM16664, 14CM17194, 14DM00236, 14DM08760, 14DM08761, 14DM13479, 14EM05451, 14EM06451, 14EM11507,14EM18730, 14EM22863, 14EM22864, 14FM01204, 14FM01205, 14FM17260, 14GM01262, 14GM03572, 14GM10619, 09EYW0010C, 09EYW0011, 09EYW0011A, 09EYW0011B, 09EYW0011C, 09EYW0011D, 09EYW0011E, 09EYW0011F, 09EYW0012, 09EYW0012A, 09EYW0012B, 09EYW0012C, 09EYW0012D, 09EYW0013, 09EYW0013A, 09EYW0013B, 09EYW0013C, 09MM09122, 10GM03167, 10GM05180, 10HM00478, 10HM00480, 10HM01652, 10HM08505, 10HM08505R, 10HM11149, 10HM11149R, 10HM16824, 10HM16824R, 10HM16824S, 10LM01590, 10MM09443, 10MM09444, 10MM09445, 11AM10566A, 11AM11219, 11AM11221, 11CM04420, 11CM06074, 11CM15011, 11DM02748, 11EM14498, 11EM16916, 11FM04754, 11FM04759, 11FM04761, 11FM04767, 11GM05674, 11GM05675, 11GM05676, 11GM10213, 11HM09823, 11HM11556, 11HM15618, 11HM15619, 11HM15620, 11HM15620A, 11JM06646, 11KM03092, 11KM03094, 11KM03095, 11KM03096, 11KM03097, 11MM06746, 11MM06746A, 11MM06894, 11MM06898, 11MM06901, 12DM10417, 12DM10420, 12DM10420A, 12EM00715, 12EM00717, 12EM00717A, 12EM04424, 12EM04425, 12EM07109, 12EM07110, 12EM07111, 12GM06808, 12GM11585, 12HM06211, 12HM06213, 12HM06213A, 12HM06215, 12HM06216, 12HM10408, 12HM11856, 12HM11857, 12HM11857R, 12JM00568, 12JM00569, 12JM00569A, 12JM00570, 12JM00571, 12JM00572, 12JM00573, 12JM04979, 12JM04981, 12JM04983, 12KM16512, 12KM16513, 14MM09041, 14MM13547, 15AM02615, 15AM08843, 15CM15790, 15DM07667, 15DM08587, 15DM10613, 15DM12768, 15DM13536, 15DM13537, 15DM20374, 15EM03979, 15FM16705, 15FM16706, 15JM03486, 15JM03487, 15JM03488, 15JM05522, 15JM05523, 15JM05524, 15JM05525, 15JM05526, 15JM14855, 15JM14999, 15JM15003, 15JM15004, 15JM15005, 15JM15006, 15JM15008, 16BM15809, 16BM15810, 16BM15811, 16BM20892, 16CM00513, 16CM01482, 16CM01483, 16CM08603, 16EM01010, 16EM01012, 16EM13209, 16EM13210, 16EM13211, 16EM18044, 16EM18046, 16FM01913, 16FM03541, 16FM11256, 16FM11257, 16FM11258, 16FM15697, 16FM15698, 16FM15699, 16FM15700, 16GM14186, 16GM14187, 16GM18830, 61005467A, 70907344A, 71106654A, 13JM09525, 14GM12600, 15JM15788, 71106655A, 13JM09526, 14GM14974, 15JM15789, 80603594A, 13JM10159, 14GM18996, 15JM15790, 80609278A, 13KM08048, 14HM04314, 15JM15791, 13KM08052, 14HM18762, 15LM09208, 13KM10776, 14JM06466, 15LM10375, 13KM22390, 14JM09489, 15LM10376, 13KM22391, 14JM10770, 15LM11432, 13LM07967, 14LM01406, 15LM11433, 13LM20117, 14LM01406R, 15LM19635, 13MM07087, 14LM09219, 15MM11292, 13MM07510, 14LM09227, 15MM11295, 13MM16218, 14LM09235, 15MM11296, 14AM09464, 14LM09245, 16AM00592, 14BM00550, 14LM09247, 16AM01881, 14BM00551, 14LM10680, 16BM15807, 14BM01666, 14MM03602, 16BM15808
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, China, Colombia, Costa Rica, Dubai, Denmark, Germany, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, South Africa, Sweden, Singapore, Switzerland, Thailand, Turkey and Venezuela.
  • Descripción del producto
    REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Dirección del fabricante
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA