Events

Rappel de Device Recall SLIFT Extension Shims

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 SpineFrontier, 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
    65760
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0274-2014
  • Date de mise en oeuvre de l'événement
    2013-08-28
  • Date de publication de l'événement
    2013-11-14
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120086
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Fit variation among all lots of s-lift extension shims with corresponding retractor blades. the firm's investigation revealed that extension shims may not fit down all retractor blades.
  • Action
    SpineFrontier sent an Urgent Voluntary Recall letter dated August 28, 2013, to all affected customers. The letter identified teh product, the problem, and the action to be taken by the customer. Customers were asked to initiate the immediate return of the parts noted and complete an acknowledgement form and return it to SpineFrontier via fax or email. Customers with questions were instructed to call 978-232-3990. For questions regarding this recall call 978-232-3990.

Device

Device Recall SLIFT Extension Shims
  • Modèle / numéro de série
    Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
  • Description du dispositif
    S-LIFT Extension Shims || Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • Adresse du fabricant
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Société-mère du fabricant (2017)
    SpineFrontier, Inc.
  • Source
    USFDA