Events

Rappel de Device Recall Contender Postop Knee Brace Full Foam

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 Corflex.

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
    72727
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0580-2016
  • Date de mise en oeuvre de l'événement
    2015-11-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142116
  • 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
    Joint, knee, external brace - Product Code ITQ
  • Cause
    Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,.
  • Action
    Corflex notified customers on November 12, 2015, initially via phone. On December 9, 2015, a follow-up letter dated December 8, 2015, was issued via email with read receipt. Customers have been instructed to return all product to Corflexs Manchester, NH manufacturing facility. This removal includes product that is new, in use and no longer in service. Customers have been provided instructions on how to contact our Customer Service department to initiate the return process and generate a Returns Material Authorization. UPS Call Tags are also being issued to facilitate the return of braces at no cost to the customer. Contact Corflex at service@corflex.com or via phone at (800) 426-7353, Monday through Friday, 8:00 am to 4:30 pm, EST

Device

Device Recall Contender Postop Knee Brace Full Foam
  • Modèle / numéro de série
    (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
  • Description du dispositif
    CONTENDER POST-OP-KNEE BRACE FULL FOAM || Model: 75-7550-000 || Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.
  • Manufacturer
    Corflex

Manufacturer

Corflex
  • Adresse du fabricant
    Corflex, 669 E Ind Park Dr, Manchester NH 03109-5625
  • Société-mère du fabricant (2017)
    Corflex Inc.
  • Source
    USFDA