Events

Rappel de SROM distal femoral cutting block guide

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
    57245
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1388-2011
  • Date de mise en oeuvre de l'événement
    2010-10-19
  • Date de publication de l'événement
    2011-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95654
  • 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
    The firm was notified that the hinge block femoral box guide cut being off alignment when using the s-rom distal femoral cutting block guide sz sml/x-sml pin holes to locate. the firm then found that the same issue was found int the med block size.
  • Action
    The firm, DePuy, sent an "URGENT INFORMATION - DEVICE CORRECTION" email and letter dated October 19, 2010 to all customers. The notices described the product, problem and actions to be taken by the customers. The notices stated that: Depuy is issuing a device correction; however, the product may still be used; the devices do not need to be returned; the distributors were to provide a letter to clinicians that were using the device; the surgical technique will be revised in October 2010; the product will undergo a design change, and the recalled product will be traded out in December 2010 and January 2011. If you have any additional questions, please contact DePuy's Scientific Information office at 1-888-554-2482. On 3/4/2011, The firm sent out a revised URGENT DEVICE RECALL asking that all affected cutting guides be taken out of service immediately. Devices should be returned to DePuy and new cutting guides will be sent out within 2 weeks.

Device

SROM distal femoral cutting block guide
  • Modèle / numéro de série
    C44AJ4000, DG9K94000, DJ5EG4000, DJ5ER4000 and DJ5EW4000.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.
  • Description du dispositif
    S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. || The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Adresse du fabricant
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA