Events

Rappel de Device Recall Panta Arthrodesis Nail

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 Corporation.

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
    55242
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0308-2011
  • Date de mise en oeuvre de l'événement
    2010-03-01
  • Date de publication de l'événement
    2010-11-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90393
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (panta support device).
  • Action
    OIntegra issued Urgent Product Recall Notification letters dated 3/1/2010 to customers and distributors to notify them of the problem. Customers were requested to check their inventory to determine if they have an of the affected devices. If so, custo0mers should stop using the product. Custoemrs with the affected product should contact their local Sales Representative for assistance, or contact Integra at 800-654-2873 - 3 to obtain a returned material authorization number, and return the product to their local representative. All customers were requested to complete and return a Recall Acknowledgement and Return Form..

Device

Device Recall Panta Arthrodesis Nail
  • Modèle / numéro de série
    Catalog number 519110, Kit S/N: PAN-001, PANTAXL-015; PAN-003, PANTAXL-017; PAN-004, PANTAXL-019; PAN-006, PANTAXL-020; PAN-013, PANTAXL-022; PAN-016, PANTAXL-026; PAN-018, PANTAXL-029; PAN-021, PANTAXL-031; PAN-023, PANTAXL-032; PAN-024, PANTAXL-033; PAN-025, PANTAXL-034; PAN-027, PANTAXL-035; PAN-030, PANTAXL-036; PAN-038, PANTAXL-039; PANTAXL-008, PANTAXL-040; PANTAXL-011, PANTAXL-042 & PANTAXL-012
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA and WI; and countries of: Australia, Austria, Belgium, Czech Republica, Denmark, Finland, France, Germany, Ireland, Italy, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
  • Description du dispositif
    Panta Support Device Panta¿ Arthrodesis Nail Instrumentation Tray One unit per package. || The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation