Events

Rappel de Device Recall Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset

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
    55119
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0500-2011
  • Date de mise en oeuvre de l'événement
    2010-02-16
  • Date de publication de l'événement
    2010-12-01
  • 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=89991
  • 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, compression - Product Code HWN
  • Cause
    The firm determined that the recalled instruments were manufactured using the wrong grade of material. as manufactured, the instruments are more brittle, increasing the potential for fracture.
  • Action
    Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall. Locate all instruments and quarantine them immediately. Count all affected product in their territory and record the data on the Inventory Return Certification Form included with the letter. Fax a copy of the completed Inventory Return Form to: Zimmer, Inc. at (574) 372-4265. Return the recalled product along with the original completed Inventory Return Certification Form to: Zimmer Distribution Center Attn: Product Service 1777 West Center Street Warsaw, IN 46580 For questions customers were instructed to contact their Zimmer Sales Representative. For questions regarding this recall call 1 - (800) 613-6131.

Device

Device Recall Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset
  • Modèle / numéro de série
    lot #'s: 60708632, 60933536, and 60978762.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Description du dispositif
    Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset, Item # 00-1179-028-02, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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