Events

Rappel de Device Recall Zimmer Natural Nail System, Tibial Targeting Guide Handle

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 Zimmer 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
    52806
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0378-2010
  • Date de mise en oeuvre de l'événement
    2009-07-01
  • Date de publication de l'événement
    2009-11-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84043
  • 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
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Action
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.

Device

Device Recall Zimmer Natural Nail System, Tibial Targeting Guide Handle
  • Modèle / numéro de série
    Lots 61161115, 61170213, 61219945, 61256543, 61233590 and 61256542.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Description du dispositif
    Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Adresse du fabricant
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA