Events

Rappel de Device Recall Integra UCR 3mm Hex, Large Axial Driver.

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
    68362
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1841-2014
  • Date de mise en oeuvre de l'événement
    2014-05-21
  • Date de publication de l'événement
    2014-06-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127469
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Cause
    Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the ucr 3mm hex, large axial driver, 91-1123 to twist or become rounded during use.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have distributed the affected product, identify those customers and forward the attached Integra Medical Device Recall Notice to them. 2. Inspect your inventory of UCR 3mm Hex, Large Axial Drivers (Catalogue Number: 91- 1123). If you have product with lot number MO16090B, STOP USING IMMEDIATELY. If you have product of any other lot number, you can continue to use it. The event has been isolated to this single lot. 3. We also request that regardless if you have a UCR Driver with the affected lot, you complete the attached form and return it to us as soon as possible as indicated. We recommend you keep a copy of the form for your records. 4. When your form is received, Customer Service will contact you and provide an RMA number, directions to return the product, and input an order to replace the quantity you indicate on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-866- 942-8698. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort. : .

Device

Device Recall Integra UCR 3mm Hex, Large Axial Driver.
  • Modèle / numéro de série
    Catalogue Number: 91- 1123. Lot No. M016090B.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution including the states of : AL, CA, OH, NM and TN.
  • Description du dispositif
    Integra UCR 3mm Hex, Large Axial Driver. || The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following 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