Events

Rappel de Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

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 DeRoyal Processing Center.

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
    61038
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1003-2012
  • Date de mise en oeuvre de l'événement
    2012-01-10
  • Date de publication de l'événement
    2012-02-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107151
  • 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
    Tray surgical - Product Code LRP
  • Cause
    The firm distributed surgical kits which contained dermahook neuro elastic retractors which were subsequently recalled by teleflex.
  • Action
    DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.

Device

Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK
  • Modèle / numéro de série
    REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    (USA) including Indiana
  • Description du dispositif
    Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits
  • Manufacturer
    DeRoyal Processing Center

Manufacturer

DeRoyal Processing Center
  • Adresse du fabricant
    DeRoyal Processing Center, 1703 Highway 33 S, New Tazewell TN 37825-5043
  • Société-mère du fabricant (2017)
    Deroyal Industries Inc.
  • Source
    USFDA