Events

Rappel de Device Recall Ankle Traction Boot

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 Allen Medical Systems, Inc..

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
    64509
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0959-2013
  • Date de mise en oeuvre de l'événement
    2013-02-28
  • Date de publication de l'événement
    2013-03-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116368
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • Cause
    Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.
  • Action
    Allen Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken. Customers were instructed to: 1. Immediately remove from service your Allen Traction Boot with the serial number(s) XXXXX 2. Contact Allen Medical Customer Service at (800) 433-5774 for an RMA number and instructions to return your Allen Traction Boot for inspection and repair if necessary. There will be no cost to you. 3. Return your Allen Traction Boot to Allen Medical as soon as possible. In order to minimize the inconvenience, we will repair your Allen Traction Boot and return the device to you within 48 hours of receipt.

Device

Device Recall Ankle Traction Boot
  • Modèle / numéro de série
    A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution- USA including the states of TX, NV, KY, GA, OH, PA, NY, AL, WA, IL and the countries of New Zealand and Japan.
  • Description du dispositif
    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.
  • Manufacturer
    Allen Medical Systems, Inc.

Manufacturer

Allen Medical Systems, Inc.
  • Adresse du fabricant
    Allen Medical Systems, Inc., One Post Office Square, Acton MA 01720
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA