Events

Rappel de Device Recall Charnley Pin Retractor and Handle Set

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
    69052
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0061-2015
  • Date de mise en oeuvre de l'événement
    2014-08-27
  • Date de publication de l'événement
    2014-10-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129458
  • 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
    Instrument, manual, surgical, general use - Product Code MDM
  • Cause
    The small extraction peg of the charnley pin retractor and handle set is breaking from the pin.
  • Action
    The firm, Depuy Synthes, sent an "URGENT INFORMATION - RECALL NOTICE" dated August 27, 2014 to their consignees. The recall notification included a description of the reason for recall, affected product, clinical implications, and instructions for responding to the formal recall notification. The customers were instructed to cease using the affected components immediately, quarantine all affected components in a manner that ensures the affected components are not used; return affected devices immediately to your DePuy; if any affected product has been forwarded to another facility, contact that facility immediately to communicate recall and arrange return; maintain awareness and copy of this notice, and complete and return the Reconciliation forms via fax to 574-371-4939 or emailed to kearle@its.jnj.com. For questions about the device recall information provided, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT) or email Kearle@its.jnj.com. For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from hospitals/user facilities, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT).

Device

Device Recall Charnley Pin Retractor and Handle Set
  • Modèle / numéro de série
    Barcode: 10603295240532 CATALOG NO. : 962004000  Lot # OSA-149328 Lot # OSA-181610  Lot # OSA-161157
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including states of: AR, CA, CO, CT, IL, MA, NC, OH, PA, TN, TX, UT, VA, WA, WI; and Internationally to: AUSTRALIA, CHILE, UK, INDIA, IRELAND, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, and SAUDI ARABIA.
  • Description du dispositif
    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. || The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.
  • 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