Events

Rappel de Device Recall Oxford Fixed Lateral Partial Knee System

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 Biomet, 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
    75901
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0956-2017
  • Date de mise en oeuvre de l'événement
    2016-12-06
  • Date de publication de l'événement
    2017-01-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151640
  • 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, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
  • Cause
    Zimmer biomet is initiating a removal of a single lot of oxford fixed lateral bearings due to mislabeling. zimmer biomet received product complaints reporting that when the package labeled as a right was opened it actually contained a left bearing.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 6, 2016. to all affected customers for a single lot of Oxford Fixed Lateral Bearings via e-mailed letter. Zimmer Biomet received two product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing. Risks: If another bearing is not available, a delay greater than 30 minutes may occur. If the product of the incorrect orientation is implanted, premature revision may be required. Customers were instructed to review the recall notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of the Inventory Return Certification Form a. Return a digital copy within three (3) days via email to corporatequality.postmarket@zimmerbiomet.com. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Inventory Return Certification Form to Zimmer Biomet. Request a Return Authorization Number via email at rgarequest@zimmerbiomet.com . Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Inventory Return Certifictaion Form via email to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Inventory Return Certifictaion Form to Zimmer Biomet with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. 5. If after reviewing this notice you have further questions or concerns please call 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, I

Device

Device Recall Oxford Fixed Lateral Partial Knee System
  • Modèle / numéro de série
    Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Date of Mfg. 26 Apr 2015
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None
  • Description du dispositif
    Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. || Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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