Retiro De Equipo (Recall) de Device Recall Miami J Collar

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 Ossur H / F.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Orthosis, cervical - Product Code IQK
  • Causa
    Ossur americas is recalling , knee shield / patella cup, knee undersleeve gray, necloc extrication collar, rebound cartilage, rebound cartilage custom, rebound air walker, rebound diabetic walker, back support suspenders clip on black, back support suspenders sew on black, extreme custom, unloader custom xt, unloader custom lite, unloader custom, and papoose infant spine immobilizers because the p.
  • Acción
    The firm sent out customer notification letters on 02/26/16. The notification letter instructed customers to include the latex caution notice in any existing inventory of affected products. The latex caution notice can be retrieved at the conclusion of the response survey or by going directly to Should customers require ¿ssur to provide pre-printed notices for existing inventory, contact ¿ssur customer service. For the ¿ssur Miami J¿ Cervical Collars with lot numbers before MX150727 customers are instructed to remove and discard the assist strap, which contains natural rubber latex, located in the patient pack. Recipients of the notice with should take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the affected devices have been transferred. 2. Maintain awareness on this notification for an appropriate period. 3. If have further distributed the products, identify customers and notify them at once of the product alert. It is recommended to include a copy of the alert notification letter. 4. If any of your customers are currently wearing a product, check for any skin irritations or other reactions consistent with natural rubber latex allergies. 5. To verify have received the notification, visit to complete the Response Survey. If any questions, contact ¿ssur Customer Service at (800) 233-6263. The notification letter for the Papoose Infant Spine Immobilizer contained the following additional actions/instructions: Examine inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product to ¿ssur. If any of customers are currently wearing a product, it is recommended replacing the unit with one shipped after the transition lot number MX150727. Check for any skin irritations or other reactions consistent with natural rubber latex allergies.


  • Modelo / Serial
    Item No: MJ-200B MJ-200L MJ-200LFRT MJ-200S MJ-200SFRT MJ-250 MJ-250FRT MJ-2530 MJ-300 MJ-300FRT MJ-400 MJ-400FRT MJ-500 MJ-500FRT MJ-P2 MJ-P3 MJR-200L MJR-200S MJR-250 MJR-2530 MJR-300 MJR-400 MJR-500 MJR-P2 MJR-P3
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
  • Descripción del producto
    Miami J Collar || Product Usage: || Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
  • Manufacturer


  • Dirección del fabricante
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Empresa matriz del fabricante (2017)
  • Source