Events

Retiro De Equipo (Recall) de Device Recall Synthes Ti Button Plate 7 holes, Fastener, Fixation, nondegradable, soft tissue

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 Synthes (USA) Products LLC.

¿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
    74418
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2138-2016
  • Fecha de inicio del evento
    2016-05-31
  • Fecha de publicación del evento
    2016-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147490
  • 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, nondegradable, soft tissue - Product Code MBI
  • Causa
    Depuy synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with mr safety information that does not meet the current astm standard.
  • Acción
    Synthes mailed to customers (Hospital Personnel and Sales Consultants) an URGENT FIELD SAFETY NOTIFICATION letter informing them the insert they received, which contained incorrect MR Safety Information, does not meet the current ASTM standards. Customers were asked to review the package insert provided with the notification letter, discard the outdated package insert, complete the attached verification Section (page 3 of this notification) and send a copy of the completed Verification Section by Fax: 844-782-5568 or scan/email: Synthes7923@stericycle.com. For further questions call (610) 719-6500.

Device

Device Recall Synthes Ti Button Plate 7 holes, Fastener, Fixation, nondegradable, soft tissue
  • Modelo / Serial
    Lot Numbers: 1749148, 1896349, 3057585, 3126474, 3277587, 3527962, 3666979, 3723149, 3754359, 3754360, 3800237, 3800239, 3825498, 4182364, 4182365, 4184238, 4184239, 4184240, 4184241, 4186156, 4186158, 4186159, 4201866, 4201867, 4201868, 4205288, 4872583, 4894156, 4894157, 4931671, 4931672, 4931673, 4952212, 4992237, 4992836, 5004334, 5083067, 5106349, 5115240, 5115241, 5127039, 5153048, 5153049, 5328496, 5337095, 5339819, 5344347, 5369177, 5391267, 5404749, 5450581, 5485082, 5510560, 5510561, 5510562, 5510563, 5510564, 5510565, 5583188, 7554579, 7554580, 7559611, 7559614, 7571578, 7571579, 7580696, 7583500, 7596250, 7780217, 7784418, 7784419, 7875460, 7923388, 7949747, 7992504, 8024598, 8060315. 8155523, 8203696, 8226175, 8238466, 8292917,8312365,8348012,8377148,8504955,8612171,8688476,8701156,8711152,8743078,8743084 8756426, 8756427, 8834945,8840904,8948836,8948838,9079710,9079712,9079716,9172619,9172621,9237247 9361663, 9361665, 9432606, 9432608, 9494467, 9494469, 9608863, 9647283, 9665152, 9671639, 9715870, 9720837, 9720840, 9783567, 9783570,. 9788216, 9801777, 9810012, 9823178, 9829378, 9836403, 9836404, 9836405, 9896775, 9913152 Part Numbers: 482.823, Device Listing Number: D194880
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA Distribution to the states of : AK,AL,AR,AZ,CA,CH,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,ON,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI, & WV
  • Descripción del producto
    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Dirección del fabricante
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA