Events

Rappel de Device Recall DePuy Synthes Titanium Recon Screws

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 Synthes, 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
    71361
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1915-2015
  • Date de mise en oeuvre de l'événement
    2015-05-27
  • Date de publication de l'événement
    2015-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137450
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    Certain lots of the titanium recon screws (6.5mm ) were found to contain the incorrect insert gp0760-a (synthes titanium buttress locking plate system), instead of the correct insert gp0706-e (synthes titanium intramedullary nails and components).
  • Action
    DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: ¿ Review the information listed in this notification. ¿ Forward this notice to anyone in your facility that needs to be informed. ¿ Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by: ¿ Fax: (888) 912-2182 or ¿ Scan/email: Synthes4844@stericycle.com ¿ If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. ¿ Maintain a copy of this notice. If you have any questions, please call (610)719-5450. Thank you for your attention to this issue.

Device

Device Recall DePuy Synthes Titanium Recon Screws
  • Modèle / numéro de série
    Part Numbers :  04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031  with Lot Numbers:  8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Adresse du fabricant
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA