Events

Rappel de Device Recall FMP Xalt Acetabular Liner

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 Djo Surgical.

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
    67468
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1130-2014
  • Date de mise en oeuvre de l'événement
    2014-02-07
  • Date de publication de l'événement
    2014-03-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125512
  • 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, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Cause
    Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. the units labeled as model/catalog number 931-28-248 lot/serial number 685f1034 on the outside and containing model/catalog number 932-36-252, lot# 728f1089 on the inside (1.
  • Action
    DJO Global sent an Urgent Field Safety Notice dated February 7, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. All 10 devices with the outer label of 931-28-248, Lot#685F1034 were found in-house and were quarantined. The agencies who have the affected product (devices labeled as 932-36-252, Lot# 728F1089 containing 931-28-248, Lot#685F1034) were contacted to quarantine their devices. Of the affected devices, 2 of the lot of 10 have already been returned via product complaint. Customers were instructed to pass on the notice to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. Customers were instructed to place a replacement order and receive an RMA number to return all affected devices.. Customers with questions were instructed to call 512-834-6255.

Device

Device Recall FMP Xalt Acetabular Liner
  • Modèle / numéro de série
    Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner)  were mistakenly packaged/labeled as  Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner)  and vice-versa
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
  • Description du dispositif
    FMP X-alt Acetabular Liner || This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
  • Manufacturer
    Djo Surgical

Manufacturer

Djo Surgical
  • Adresse du fabricant
    Djo Surgical, 9800 Metric Blvd, Austin TX 78758-5445
  • Source
    USFDA