Events

Rappel de Device Recall PERPOS PLS SYSTEM

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 Interventional Spine 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
    58465
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2718-2011
  • Date de mise en oeuvre de l'événement
    2011-03-23
  • Date de publication de l'événement
    2011-07-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99407
  • 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
    This recall has been initiated due to k-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. removing the k-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw.
  • Action
    Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once. Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance. For further questions, please call (949) 472-0006

Device

Device Recall PERPOS PLS SYSTEM
  • Modèle / numéro de série
    LOT #'s: 040309-A, 041409-A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of to NC, NY, TN & VA
  • Description du dispositif
    PERPOS PLS SYSTEM, CATALOG NO. 9045-01 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.
  • Manufacturer
    Interventional Spine Inc

Manufacturer

Interventional Spine Inc
  • Adresse du fabricant
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Société-mère du fabricant (2017)
    Interventional Spine Inc.
  • Source
    USFDA