Events

Retiro De Equipo (Recall) de REALIZE

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 Ethicon Endo-Surgery 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
    66465
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0149-2014
  • Fecha de publicación del evento
    2013-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122436
  • 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
    Implant, intragastric for morbid obesity - Product Code LTI
  • Causa
    During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for force to lock.
  • Acción
    Ethicon sent an Urgent: Medical Device Recall letter dated September 30, 2013 to affected consignees via overnight, UPS to allow tracking of the receipt. The letter identified affected products, problem and actions to be taken. Each consignee is requested to respond to a provided Business Reply Form (BRF), indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. For questions contact your local sales representative or call our Customer Support Center 1-877-384-4266 option 6.

Device

REALIZE
  • Modelo / Serial
    The following product code and lot numbers were affected by this recall: Product Codes: RLZB22 Lot Numbers: ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7, ZLFBFB, ZLLBCR, ZLLBFT, ZLMBCH, ZLMBWD, ZLNBBF, ZLNBGZ, ZMCBDH, ZMDBCH, ZMFBC4, ZMGBBF, ZMGBC1, ZMHBBW, ZMJBHV, ZMKBBH, ZMLBCJ, ZMNBCK, ZNBBD2, ZNFBCC, ZNHBCM, and ZNLBB4.   Product Codes: RLZB22D1 Lot Numbers: G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TT4D, G4TU2V, G4TV3T, G4TW6D, G4U17U, G4U75W, G4U795, G4UD6T, G4UF6Y, G4UG4E, G4UH49, G4UH4K, H43A3N, H43C8P, H43E9V, H43J2P, H43N12, H43N42, H43P5U, H43P9C, H43T3F, H43U78, H43V8J, H43X4K, H43Z8Y, H4453N, H44623, H4478W, H44965, H44C9G, H44D8W, H44K3G, H44K9M, H44N0X, H44R1Y, H44R4U, H44T9D, H44V39, H44W6H, H44Y24, H44Z0Y, J4A04D, J4A11V, J4A274, J4A668, J4A81X, J4A96M, J4AC6L, J4AE3P, J4AH2Z, J4AK89, J4AN34, J4AU9R, J4AW1Y, J4C35K, J4C76E, J4CE9V, K4C518, K4CE4L, K4CT8W, K4D17T, and K4D45Y.   Product Codes: RLZB22DG1 Lot Numbers: G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V, G4U184, G4U734, G4UD77, G4UF9V, G4UH6P, H43A3P, H43C8R, H43G7Y, H43T3K, H43U7E, H43X1G, H43Z5Y, H44645, H44H9M, H44K2T, H44L44, H44V3A, H44W6G, H44Y25, H44Z0X, H44Z3N, J4A48K, J4AA11, J4AL00, J4AR9K, and K4CE6X .  Product Codes: RLZB22DGT Lot Numbers: G4U323, J4AY55, and K4C663.   Product Codes: RLZB22DT Lot Numbers: G4UD92, H44D1Y, J4AY72, and K4C666.   Product Codes: RLZB22T Lot Numbers: G4RE82
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.
  • Descripción del producto
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. || Product Usage: || Intended for use in surgical treatment of morbid obesity
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Dirección del fabricante
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA