Events

Rappel de Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm

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 Integra LifeSciences 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
    74224
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2084-2016
  • Date de mise en oeuvre de l'événement
    2016-05-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146870
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Cause
    The affected k-wires do not meet specification requirements. specifically, a) k-wires were made of 316lvm stainless steel instead of 304 stainless steel. b) k-wires have passivated surface finish instead of electro-polish surface finish. c) k-wires have incorrect length and diameter.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.

Device

Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm
  • Modèle / numéro de série
    Lot 237830TE
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
  • Description du dispositif
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System || The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.