Events

Rappel de Device Recall Malibu Polyaxial Screw

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 SeaSpine, 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
    52115
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1920-2009
  • Date de mise en oeuvre de l'événement
    2009-03-04
  • Date de publication de l'événement
    2009-09-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82128
  • 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
    Spinal Interlaminal Fixation Appliance - Product Code KWP
  • Cause
    Seaspine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain malibu polyaxial and malibu reduction screws.
  • Action
    In an Urgent Voluntary Product Recall Notification letter dated March 5th, 2009, SeaSpine informed consignees about the reason for recall and asked them to immediately check the products in their possession and hospital inventories to determine if they have any of the affected product. Alternatively, there were told if they would prefer to return to SeaSpine all Malibu Screw inventory that is in their possession, SeaSpine will sort out the affected product upon receipt and will replace their inventory with Malibu Screws that conform to all SeaSpine specifications. The part number and lot are laser marked on the outside of the seat assembly of each screw. SeaSpine asked their consignees to return affected product to them immediately. Attached was a verification form, that they were told to complete and return even if they did not have any product to return. Furthermore their local Sales Manager could assist them in completing the form. They were also encouraged to contact their Sales Manager or Steve Rybka at (760) 727-8399 x202 if they had any questions regarding the recall, any of their products, or would like assistance with the recall.

Device

Device Recall Malibu Polyaxial Screw
  • Modèle / numéro de série
    Lot Number: A1720A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  • Description du dispositif
    Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 || Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
  • Manufacturer
    SeaSpine, Inc

Manufacturer

SeaSpine, Inc
  • Adresse du fabricant
    SeaSpine, Inc, 2302 La Mirada Dr, Vista CA 92081-7862
  • Source
    USFDA