Retiro De Equipo (Recall) de Device Recall Synthes Torque Limiting Handle

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País 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
    Screwdriver - Product Code HXX
  • Causa
    The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
  • Acción
    An Urgent Medical Device Recall Notification letters dated May 4, 2018, were distributed to customers. The letter requests that customers take the following actions: Potential Patient Impact: The subject, Torque Limiting Handle, may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft of the driver component. In addition, the ball bearings may corrode over time causing a failure in the torque limiting feature. The following potential scenarios could occur: " Malunion/nonunion and device loosening if there is a degradation of function and too much or too little torque is applied. " Adverse tissue reaction if there is corrosion and any debris enters an open incision. " Surgical delay due to the time required to investigate and decide next steps if the instrument fails during surgery. If you have no product to be returned: " Return the Verification Section (page 3 of this letter) to DePuy Synthes by: o Fax: 866-853-1969 or o Scan/email: NOTE: If the Verification Section is completed on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page number three (3) of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of this notice visibly posted for awareness until all product subject to this recall (removal) have been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. For further questions, please call (610) 719-5450.


  • Modelo / Serial
    H344006-02,  H344006-03,  H344006-04,  H344006-05,  H344006-06,  H344006-07,  H344006-08,  H344006-09,  H344006-10,  H344006-11,  H344006-12,  H344006-13,  H344006-14,  H344006-15,  H344006-16,  H344006-17,  H344006-18,  H344006-19,  H344006-20,  H344006-21,  H344006-22,  H344006-23,  H344006-24,  H344006-25,  H344006-26,  H344006-27,  H344006-28,  H344006-29,  H344006-30,  H344006-31,  H344006-32,  H344006-33,  H344006-34,  H344006-35,  H344006-36,  H344006-37,  H344006-38,  H344006-39,  H344006-40,  H344006-41,  H344006-43,  H344006-45,  H344006-46,  H344006-47,  H344006-48,  H344006-49,  H369323-03,  H369323-04
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    USA (nationwide) Distribution to the states of : AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV.
  • Descripción del producto
    Synthes Torque Limiting Handle, Part Number 03.231.013 || This device is used in systems indicated for fracture fixation.
  • Manufacturer


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