Events

Rappel de Device Recall ReClaim Reamer Extension

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 DePuy Orthopaedics, 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
    64285
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0972-2013
  • Date de mise en oeuvre de l'événement
    2013-02-25
  • Date de publication de l'événement
    2013-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115761
  • 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
    Reamer - Product Code HTO
  • Cause
    The tabs on the reamer extension device have broken. depuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. once the root cause is determined and a design change is implemented, depuy will conduct a formal swap-out of the affected devices.
  • Action
    DePuy Synthes sent a Urgent Information Medical Device Correction Notice to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed upon visual inspection, if the reamer extension is found to have one or more tabs broken, please do not use the reamer extension. The reamer extension will still engage with one tab intact and no clinical implications have been identified with the use of the reamer extension with one tab, but DePuy recommends it be returned and the alternate reamer extension device be used. If both tabs are broken, the reamer extension will not engage and DePuy recommends it be returned and the alternate reamer extension device be used. A reamer extractor is available in the instrument kit for removal of the reamer if necessary. In order to reduce the risk of breaking the tabs during surgery, the Reamer Extension should only be used to drive the Distal Reamer axially within the patients femoral canal. The instrument is NOT intended to be used for side-cutting or lateralizing the femoral canal, therefore, no off-axis force should be applied during distal reaming. The purpose of this communication is to inform you of this device correction and request acknowledgement of receipt of this letter by signing and returning the Surgeon Response Card within 14 days of receiving this notice. Response cards should be faxed to Fax Number: 574-371-4939. For product-related questions, please contact your local DePuy Orthopaedics Sales Representative. For clinical-related questions from surgeons, please have them contact DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am to 5 pm EST.) For questions about device correction information provided, 574-372-7333 (M-F: 8 am to 5 pm EST.)

Device

Device Recall ReClaim Reamer Extension
  • Modèle / numéro de série
    Engraved Lot Number/ Label Lot Number J0111 / 578910  578913  R578910  R578912  R578913  In Kit # 2975-50-025 J0211/ In Kit # 2975-50-025 J0411/ 582631  In Kit # 2975-50-025 J0611/ In Kit # 2975-50-025 J0911/ 592125  In Kit # 2975-50-025 J1211/ 000003583  In Kit # 2975-50-025 NB12649 / NB12649 NB12650 / NB12650 NB12651 / NB12651 NB12652 / NB12652 NB12653/ NB12653 NB12654/ NB12654 NB12655/ NB12655 NB12656/ NB12656 NB23480/ NB23480 NB23481/ NB23481 NB3584 / In Kit # 2975-50-025 NB3586 / NB3586 NB3587 / NB3587 NB3588 / In Kit # 2975-50-025 NB3590 / NB3590 NB3591 / In Kit # 2975-50-025 NB5955 / NB5955 NB7894 / NB7894  In Kit # 2975-50-025 NB8016 / In Kit # 2975-50-025 NB8017 / NB8017 NB8018 / NB8018  In Kit # 2975-50-025 NB8019 / In Kit # 2975-50-025 NB8020 / NB8020 NB8021 / NB8021 NB8022 / NB8022 NB8023 /NB8023
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of Canada, Chile, Germany, Czech Republic, Israel , Norway, Poland, Slovenia, Australia, New Zealand, South Africa, Belgium, Austria, Switzerland, France, England and County Cork, Ireland.
  • Description du dispositif
    ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA