Events

Rappel de Device Recall DePuy Synthes orthopedic instruments

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
    76023
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2317-2017
  • Date de mise en oeuvre de l'événement
    2017-01-06
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151963
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Products were made outside of quality system regulation, and potentially outside of premarket submission (510k/pma) for certain devices. the safety or effectiveness of these devices cannot be assured.
  • Action
    DePuy Synthes sent an URGENT INFORMATION  RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS dated January 6, 2017, to all affected customers. . Customerss were instructed to identify all medical facilities that may have used or received the affected instruments and identify the modified instruments used at each facility. This information was to be used to generate Reconciliation Forms for each impacted Medical Facility. The Reconciliation Forms and URGENT INFORMATION  RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS recall notifications were then delivered by DePuy Synthes Sales Consultants to the affected medical facilities. Instructions in the URGENT INFORMATION  RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS provided to the medical facilities included the following: Please take the following actions: " Please immediately cease using the modified instruments identified in the attached Reconciliation Form. Your U.S. DePuy Synthes Sales consultant will work with your facility to locate and replace any affected instruments. " If your facility is using an instrument that was created or modified by a DePuy Distributor at the request of a surgeon, and it is not listed on the attached Reconciliation Form, please contact your DePuy Synthes Sales Consultant for an evaluation to determine if the instrument should be returned and replaced. WI-9956 | Rev 5 | Attachment B2 " Return Affected Instruments: o Medical facilities are to determine if any of the recalled instruments are still on hand by working with your U.S. DePuy Synthes Sales Consultant, and return affected devices immediately to their U.S. DePuy Synthes Sales Consultant or return them to DePuy Orthopaedics, Inc. for credit following normal purchasing procedures. o Note: These instruments may be on consignment at your facility. " Reconciliation Form: Complete the Reconciliation Form and return to your U.S. DePuy Synthes Sales Consultant or

Device

Device Recall DePuy Synthes orthopedic instruments
  • Modèle / numéro de série
    Unknown
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
  • Description du dispositif
    DePuy Synthes || various orthopedic instruments modified by U.S. Distributors || These instruments are used in various orthopedic procedures
  • 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