Events

Rappel de Device Recall Malibu Polyaxial Screwdriver

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 Integra LifeSciences Corp..

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
    67350
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0938-2014
  • Date de mise en oeuvre de l'événement
    2014-01-22
  • Date de publication de l'événement
    2014-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125305
  • 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 lifesciences has identified through an investigation of complaints that there may be the potential for the shaft of the malibu polyaxial drivers to break during use. none of the complaints reported a patient injury. however, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.
  • Action
    Integra LifeSciences initiated this recall by sending recall notification letter to US consignees, delivered by traceable courier service. Non US consignees notified of the recall by either traceable e-mail or facsimile. The letter dated, January 23, 2014, titled "URGENT: VOLUNTARY MEDICAL DEVICE RECALL Integra¿ Malibu Polyaxial Drivers Catalogue Numbers: 91-2109 & 91- 2110", informed customers of the recall and provided product description with codes, picture of the product, advised customers to: Inspect their inventory of Malibu Polyaxial Drivers. - If you have product(s) with a lot number listed on the following page, STOP USING THEM IMMEDIATLY. - If you do not have Drivers with a lot number listed on the following page, you can continue to use them. Customers were also instructed that regardless if they have Drivers with the affected lots, to complete the attached form and return it to Integra as indicated. Customers were instructed to keep a copy of the form for their records., and contact information. Customers with questions were instructed to contact Customers Service at 1-866-942-8698. For questions regarding this recall call 609-275-0500.

Device

Device Recall Malibu Polyaxial Screwdriver
  • Modèle / numéro de série
    Model Number(s):  91-2109 (8.0 Plus)  91-2110 (Standard).  Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard.  The devices are not distributed as sterile and do not have a expiration date.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.
  • Description du dispositif
    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; || Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. || 510(k): || 91-2109 K061342. || 91-2110 K051942. || The Malibu" System is 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. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.