Events

Rappel de Device Recall Gliding Nail Radiolucent Guide instrument set

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 Plus Orthopedics USA.

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
    35054
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0928-06
  • Date de mise en oeuvre de l'événement
    2006-02-22
  • Date de publication de l'événement
    2006-06-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45198
  • 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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
  • Cause
    Plus usa has been informed by plus ag that the accuracy of the instrument set may be affected in some cases. it is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
  • Action
    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment.

Device

Device Recall Gliding Nail Radiolucent Guide instrument set
  • Modèle / numéro de série
    Revision A Serial Number: None
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The 5 sets were distributed in the following states: 1) California, 2) Idaho, and 3) New York.
  • Description du dispositif
    Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: || 1130020-A: GNp Carbon Targeting Handle || 1130021-A: GN Adapter Screw for Handle SW 10 || 1130022-A: GN Targeting Guide Carbon 125¿ || 1130023-A: GN Targeting Guide Carbon 135¿ || 1130060-A: GNp Drill Guide Locking No. 3 || 1133158-A: GN Centering Sleeve New Guide || Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • Adresse du fabricant
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA