Events

Rappel de Trochar Scalpel Instrument (Surgical Punch)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par OrthoPediatrics Corp.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63396
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0207-2013
  • Date de mise en oeuvre de l'événement
    2012-09-13
  • Date de publication de l'événement
    2012-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113679
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Mixture, hematology quality control - Product Code HSB
  • Cause
    A complaint received from sales representative that a replenishment instrument was too short. upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
  • Action
    OrthoPediatrics Corp sent an Urgent Recall e-mail dated September 14, 2012, to all affected customers. The e-mail identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all identified devices from the affected lot numbers immediately. Customers were also asked to complete the Mandatory Reply Form. Customers with questions should call 574-268-6379.

Device

Trochar Scalpel Instrument (Surgical Punch)
  • Modèle / numéro de série
    Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
  • Description du dispositif
    Trochar Scalpel Instrument (Surgical Punch) || OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • Adresse du fabricant
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Société-mère du fabricant (2017)
    Orthopediatrics Corp
  • Source
    USFDA