Events

Rappel de Mercury Spinal System

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 Spinal Elements, 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
    70950
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1597-2015
  • Date de mise en oeuvre de l'événement
    2015-04-09
  • Date de publication de l'événement
    2015-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135713
  • 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
    Some rods may not meet the appropriate traceability requirements including the lot number. some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. the lack of marking interrupts the ability to maintain traceability of the device.
  • Action
    The firm sent customer notification letters on 04/09/15. In this letter the firm requested that all affected lots be returned, and replacement inventory will be made available. The firm requested that customers take the following actions: 1. Immediately examine inventory for part number 60100-045. 2. Immediately discontinue the use and/or distribution of the affected lots 3. Send all affected product back to: Spinal Elements, Inc. ATTN: Julie Lamothe 3115 Melrose Drive Carlsbad, CA 92010 4. If further distributed the product to please identify the customers and notify them as once. 5. Complete and return the enclosed "Customer Response Form." Any questions the firm states to contact the Customer Service department at 1.877.SPINAL5 Ext. 213.

Device

Mercury Spinal System
  • Modèle / numéro de série
    Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.
  • Description du dispositif
    Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.
  • Manufacturer
    Spinal Elements, Inc

Manufacturer

Spinal Elements, Inc
  • Adresse du fabricant
    Spinal Elements, Inc, 3115 Melrose Dr Suite 200, Carlsbad CA 92010-6690
  • Société-mère du fabricant (2017)
    Spinal Elements
  • Source
    USFDA