Events

Rappel de Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold")

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 Orthopedic Alliance LLC.

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
    64584
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1156-2013
  • Date de mise en oeuvre de l'événement
    2013-03-07
  • Date de publication de l'événement
    2013-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116550
  • 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 - Product Code MNI
  • Cause
    Orthopedic alliance is recalling blue & gold implants and instruments because the blue & gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. these inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.
  • Action
    A recall letter dated March 7, 2013 was sent to one customer who purchased the Blue & Gold Implants and instruments. The letter informed the customer that the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization. Customer is informed of the actions to be taken. Customer is instructed to complete the customer response form and return it by FAX to (858) 764-9739.

Device

Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold")
  • Modèle / numéro de série
    All lots are being recalled.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in Texas.
  • Description du dispositif
    Orthopedic Alliance Spine System (alias "Blue & Gold") || Part Numbers: || BGC3010 Screw Cap || BGR0040 Straight Rod 5.5 x 40mm || BGR0050 Straight Rod 5.5 x 50mm || BGR0060 Straight Rod 5.5 x 60mm || BGR0070 Straight Rod 5.5 x 70mm || BGR0080 Straight Rod 5.5 x 80mm || BGR0090 Straight Rod 5.5 x 90mm || BGR0100 Straight Rod 5.5 x 100mm || BGR0110 Straight Rod 5.5 x 110mm || BGR0120 Straight Rod 5.5 x 120mm || BGR0130 Straight Rod 5.5 x 130mm || BGR0140 Straight Rod 5.5 x 140mm || BGR0150 Straight Rod 5.5 x 150mm || BGR0200 Straight Rod 5.5 x 200mm || BGR0300 Straight Rod 5.5 x 300mm || BGR0400 Straight Rod 5.5 x 400mm || BGR0500 Straight Rod 5.5 x 500mm || BGS5535 5.5 x 35mm Polyaxial Screw || BGS5540 5.5 x 40mm Polyaxial Screw || BGS5545 5.5 x 45mm Polyaxial Screw || BGS6035 6.0 x 35mm Polyaxial Screw || BGS6040 6.0 x 40mm Polyaxial Screw || BGS6045 6.0 x 45mm Polyaxial Screw || BGS6050 6.0 x 50mm Polyaxial Screw || BGS6535 6.5 x 35mm Polyaxial Screw || BGS6540 6.5 x 40mm Polyaxial Screw || BGS6545 6.5 x 45mm Polyaxial Screw || BGS6550 6.5 x 50mm Polyaxial Screw || BGS7035 7.0 x 35mm Polyaxial Screw || BGS7040 7.0 x 40mm Polyaxial Screw || BGS7045 7.0 x 45mm Polyaxial Screw || BGS7050 7.0 x 50mm Polyaxial Screw || BGS7055 7.0 x 55mm Polyaxial Screw || BGS7535 7.5 x 35mm Polyaxial Screw || BGS7540 7.5 x 40mm Polyaxial Screw || BGS7545 7.5 x 45mm Polyaxial Screw || A pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
    Orthopedic Alliance LLC

Manufacturer

Orthopedic Alliance LLC
  • Adresse du fabricant
    Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA