Events

Rappel de Device Recall Femoral component

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 Orthopedic Alliance LLC.

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
    64588
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1378-2013
  • Date de mise en oeuvre de l'événement
    2013-02-20
  • Date de publication de l'événement
    2013-05-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116554
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    The recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Action
    A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Device

Device Recall Femoral component
  • Modèle / numéro de série
    Catalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
  • Description du dispositif
    Femoral component, CR, cemented, #1, left 2103-1310 || Femoral component, CR, cemented, #2, left 2103-1320 || Femoral component, CR, cemented, #3, left 2103-1330 || Femoral component, CR, cemented, #4, left 2103-1340 || Femoral component, CR, cemented, #5, left 2103-1350 || Femoral component, CR, cemented, #6, left 2103-1360 || Femoral component, CR, cemented, #1, right 2103-1410 || Femoral component, CR, cemented, #2, right 2103-1420 || Femoral component, CR, cemented, #3, right 2103-1430 || Femoral component, CR, cemented, #4, right 2103-1440 || Femoral component, CR, cemented, #5, right 2103-1450 || Femoral component, CR, cemented, #6, right 2103-1460 || Femoral component, PS, #1, left 2103-3110 || Femoral component, PS, #2, left 2103-3120 || Femoral component, PS, #3, left 2103-3130 || Femoral component, PS, #4, left 2103-3140 || Femoral component, PS, #5, left 2103-3150 || Femoral component, PS, #6, left 2103-3160 || Femoral component,PS, #1, right 2103-3210 || Femoral component,PS, #2, right 2103-3220 || Femoral component,PS, #3, right 2103-3230 || Femoral component,PS, #4, right 2103-3240 || Femoral component,PS, #5, right 2103-3250 || Femoral component,PS, #6, right 2103-3260 || Variety of hip and knee implants and instruments, multiple uses.
  • Manufacturer
    Orthopedic Alliance LLC

Manufacturer

Orthopedic Alliance LLC
  • Adresse du fabricant
    Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA