Events

Rappel de iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL

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 Arthrex, 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
    78297
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0095-2018
  • Date de mise en oeuvre de l'événement
    2017-10-03
  • Statut de l'événement
    Completed
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159082
  • 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, non-constrained, cemented, metal/polymer - Product Code HSX
  • Cause
    Arthrex part number ar-501-uflc, size 3, batch 10123297, has the incorrect part number ar-501 ¿ufra, size 1 printed on the patient label inside the box.
  • Action
    Arthrex sent an Urgent Medical Device Voluntary Recall letter on October 3, 2017. The letter requested the following: "Immediately discontinue use of these devices. In order to receive credit for the returned devices, please follow the steps below: 1) Review this notification and ensure affected personnel are aware of the contents. 2) Immediately identify and return all the indicated product/batch numbers you have in inventory. Call Arthrex Field Logistics Service at 1-866¿612-7899 for a returned goods authorization (RGA) and product return instructions. Email: FLS@Arthrex.com." Customers with questions were instructed to call Product Surveillance at 866-267-9138 or by email to commplaints@arthrex.com.

Device

iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL
  • Modèle / numéro de série
    batch 10123297
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
  • Description du dispositif
    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL || Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
  • Manufacturer
    Arthrex, Inc.

Manufacturer

Arthrex, Inc.
  • Adresse du fabricant
    Arthrex, Inc., 1370 Creekside Blvd, Naples FL 34108-1945
  • Société-mère du fabricant (2017)
    Arthrex, Inc.
  • Source
    USFDA