Events

Rappel de 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM

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
    66450
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0276-2014
  • Date de publication de l'événement
    2013-11-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122418
  • 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
    Plate, fixation, bone - Product Code HRS
  • Cause
    The firm identified, through complaints that the 3.5mm locking screw packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. upon investigation, it has been determined that a lot number 009u2 was packaged and mislabeled internally by orthopediatrics.
  • Action
    OrthoPediatrics sent an Urgent Medical Device Recall letter dated September 26, 2013, to all affected customers.The letter identified the product the problem and the actions needed to be taken by the customer The sales representatives and distributors who have been identified via shipping records as having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on 18-September-2013. If you or any of your customers have any of these devices in the original packaging please take possession of them and quarantine them in preparation for returning them to OrthoPedlatrics. They are misbranded. If the Screw has already been removed from the original packaging and the original packaging has been discarded and the Screw placed in a sterilization tray, it need not be returned. For further questions please call ( 574) 268-6379.

Device

3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM
  • Modèle / numéro de série
    Part Number:. 00-0903-2634 and lot number 009U2
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
  • Description du dispositif
    3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM || The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
  • 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