Events

Retiro De Equipo (Recall) de Device Recall Mini MaxLock Extreme Plating System Case and Tray

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 Orthohelix Surgical Designs 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
    59462
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3081-2011
  • Fecha de inicio del evento
    2011-07-06
  • Fecha de publicación del evento
    2011-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102838
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    The surgical tray does not meet our instruction for use (ifu) for dry time requirement.
  • Acción
    Orthohelix Surgical Designs Inc sent a RECALL NOTIFICATION letter dated July 6, 2011 and an UPDATED URGENT RECALL 2ND NOTIFICATION letter dated July 13, 2011 to all affected customers. The letter identified the recalled product, the problem, and the Field Correction actions to be taken. Customers were instructed to remove the blue rubber mat in the utility bay of the tray base immediately, tag the mat with the tray number, and return it to recalling firm immediately. The letter states once customers have removed the blue rubber mat from the tray base, they may continue to use the tray and system normally. No further actions or precautions are needed. Distributors were also asked to notify their customers of the recall. If you have any questions, please call 330-247-1444 or 330-247-1445.

Device

Device Recall Mini MaxLock Extreme Plating System Case and Tray
  • Modelo / Serial
    Model Number(s): MXM-901; Tray codes affected: LAQ, LAV, LCL, LCN, LBZ, LCA, LBV, LCU, LAR, LBJ, LBT, LDE, LDG, LBL, LCD, LBI, LCI, LBQ, LCV, LBK, LBC, LCW, LCB, LDH, LBM, LCM, LCK, LDB, LBS, LCE, LDD, LDF, LAX, LDI, LAP, LBH, LBP, LAO, LBB, LBE, LBX, LCH, LAT, LAS, LCR, LDC, LAW, LCJ, LDJ, LCZ, LAU, LBF, LCQ, LBN, LCP, LCX, LBU, LBW, LBY, LCT, LCY, LAY, LAZ, LBA, LBD, LBG, LBO, LBR, LCC, LCF, LCG, LCS, LDA, LDM, LDN, LDO, LDP, LDQ, LDR, LDS, LDT, LDU & LDK.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA Nationwide Distribution including the states of: AR, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI & WY.
  • Descripción del producto
    Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, || Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation.
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • Dirección del fabricante
    Orthohelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina OH 44256
  • Empresa matriz del fabricante (2017)
    Wright Medical Group NV
  • Source
    USFDA