Events

Rappel de Device Recall Bone fixation fastener

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 EXP Pharmaceutical Services 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
    71608
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2214-2015
  • Date de mise en oeuvre de l'événement
    2015-02-11
  • Date de publication de l'événement
    2015-07-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138360
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Cause
    Exp did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
  • Action
    EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.

Device

Device Recall Bone fixation fastener
  • Modèle / numéro de série
    OEM Catalog number AR-1927BCF.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Description du dispositif
    Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, || Vented Suture Anchor; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number AR-1927BCF; || EXP (repackager), Arthrex (OEM) || Fastener, fixation, nondegradable, soft tissue
  • Manufacturer
    EXP Pharmaceutical Services Corp

Manufacturer

EXP Pharmaceutical Services Corp
  • Adresse du fabricant
    EXP Pharmaceutical Services Corp, 48021Warm Springs Boulevard, Fremont CA 94539
  • Société-mère du fabricant (2017)
    Abry Partners Inc.
  • Source
    USFDA