Events

Rappel de Device Recall Reprocessed Mitek Arthroscopic Wand

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 Stryker Sustainability Solutions, 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
    61296
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1204-2012
  • Date de mise en oeuvre de l'événement
    2009-06-01
  • Date de publication de l'événement
    2012-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107760
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    On 06/09/2009, stryker sustain ability solutions, formerly ascent healthcare solutions, recalled lots 674201 & 674290 of their reprocessed mitek arthroscopic wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09.
  • Action
    Ascent Healthcare Solutions notified their customers by presenting a letter dated June 1, 2009 from an Ascent Representative. The representative was to recover any products that may have been affected. Questions were directed to 1-888-888-3433.

Device

Device Recall Reprocessed Mitek Arthroscopic Wand
  • Modèle / numéro de série
    Model # 225301 Lot #s: 674201 & 674290 Expiration dates: 04/2012
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA), including the states of: TX, NY, MN, CA, and CT.
  • Description du dispositif
    The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions. || The outer box of the Reprocessed Mitek Arthroscopic Wand is labeled in part: "***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***Contents sterile by EO unless package is opened or damaged.***Reprocessed Device for single use. Reprocessed By Ascent Healthcare Solutions.***Cat #: 225301 MITEK 3.5mm SIDE EFFECT ELECTRODE***Lot #: 674290 Expiration Date: 04/2012***" || Individual pouch labeled in part: "***Cat #: 225301***MITEK 3.5mm SIDE EFFECT ELECTRODE****IFU at www.ascenths.com***Contents: One Expiration Date 04/2012***Lot # 674201 ID# 0***Reprocessed by Ascent Healthcare Solutions Not affiliated with the original manufacturer.***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***"
  • Manufacturer
    Stryker Sustainability Solutions, Inc.

Manufacturer

Stryker Sustainability Solutions, Inc.
  • Adresse du fabricant
    Stryker Sustainability Solutions, Inc., 5307 Great Oak Dr, Lakeland FL 33815-3113
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA