Events

Rappel de Device Recall NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR

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
    58180
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2173-2011
  • Date de mise en oeuvre de l'événement
    2011-03-14
  • Date de publication de l'événement
    2011-05-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98606
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Cause
    The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. the firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.
  • Action
    The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" notice dated March 14, 2011 to its Consignees/customers. The letter described the product, problem, and the actions to be taken. The customers were instructed to stop using the device and quarantine immediately; carry out a physical count of all affected product in their territory and record this data on the Inventory Return Certification Form and fax to (574) 372-4265; ensure they have provided acknowledgement via "email return receipt" upon receiving notification; return the recalled product along with the completed Inventory Return Certification Form and Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580-Note: The instrument must be returned even if the spring clip is not missing from the instrument; and if they distributed these affected lots further, provide a copy of this letter to the those customers when they implement these recall instructions. The letter stated that a new or refurbished instrument with a redesigned spring clip will be provided as replacement for the recalled device. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc. at 1-800-613-6131.

Device

Device Recall NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR
  • Modèle / numéro de série
    61516146, 61522231, 61542077, 61550613, 61565681, 61584069, 61584438, 61594876, 61610343, 61637191, 61657309, 61659596 61675231, 61691488, 61701224 and 61708918.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden.
  • Description du dispositif
    NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00, Zimmer UK, Ltd., Zimmer Warsaw, IN. || Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Adresse du fabricant
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA