Events

Retiro De Equipo (Recall) de Device Recall Depuy Mitek Lupine (Panalok) Loop Arthro 2 Ethibond

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 DePuy Mitek, Inc., a Johnson & Johnson Co..

¿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
    61088
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1162-2012
  • Fecha de inicio del evento
    2012-01-27
  • Fecha de publicación del evento
    2012-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107268
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Causa
    Lupine br anchor w/ orthocord may be assembled with an incorrect suture configuration and result in a loose repair.
  • Acción
    DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871.

Device

Device Recall Depuy Mitek Lupine (Panalok) Loop Arthro 2 Ethibond
  • Modelo / Serial
    Lot Numbers: 3254455 3254464 3254772 3262313 3270104 3276492 3278110 3278111 3286624 3286916 3286917 3286918 3287309 3287311 3287390 3287392 3295568 3295569 3297682 3297683 3299220 3304047 3304048 3304049 3305321 3305430 3305681 3305682 3305683 3306004 3306391 3306677 3307006 3334454 3334455 3334634 3334635 3345378 3345379 3370177 3370178 3370180 3370783 3371236 3371239 3371241 3371615 3377559 3377561 3377562 3383125 3383127 3383265 3383266 3383267 3383268 3383623 3384221 3384222 3396398 3396503 3396504 3397755 3412266 3412270 3412856 3414484 3414533 3415555 3415714 3416128 3417104 3418602 3420846 3423623 3424661 3425288 3426996 3427237 3427238 3428991 3432156 3433007 3437113 3442445 3443870 3447918 3450122 3451457 3456002 3456269 3456435 3459762 3464533 3466040 3468840 3471144 3473778 3476081 3477621 3478976 3484026 3486327 3489054 3489725 3491267 3494653 3494656 3494917 3501542 3502156 3502967 3503801 3504239 3507680 3508146 3508905 3509441 3509538 3509541 3509956 3510410 3511003 3518413 3523828 3527730 3528739 3531511 3533828 3540939 3541612 3542349 3549274 3551177 3556763 3556770 3560268 3564054 3570366 3570374 3571653
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Finland, Great Britain, Guadeloupe, Hong Kong, Hungary,Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Luxembourg,Latvia, Martinique, Montenegro, Mexico, Maylasia, Netherlands,Norway, New Zealand, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Tunisia, Turkey,Uruguay, Venezuela, and South Africa
  • Descripción del producto
    Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond || Catalog Number: 210704 || The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Dirección del fabricante
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA