Events

Rappel de Device Recall Pinnacle

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 DePuy Orthopaedics, 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
    61315
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1366-2013
  • Date de mise en oeuvre de l'événement
    2012-03-07
  • Date de publication de l'événement
    2013-05-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107791
  • 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
    Depuy orthopaedics, inc. (depuy) is issuing a voluntary recall of one lot of the altrx" liner because the product was incorrectly labeled on the box. the box was labeled for a 36idx52od +4 neutral liner, but the product enclosed was a 36idx56od neutral liner. three ( 3 ) complaints were received in january 2012.
  • Action
    DePuy Orthopaedics sent an URGENT INFORMATION- MEDICAL DEVICE RECALL NOTICE dated March 7, 2012 via email to all affected distributors and customers. The letter identified the affected product, problem and actions to be taken. Distributors and customers are instructed to cease further distribution or use or of recalled product and to return them to DePuy. The sales representatives are expected to aid customer in returning of recalled product. Distributors and sales representatives are to return the recalled product through the normal DePuy Returns process. Reconciliation form should be completed and returned to your DePuy Sales Representative or faxed to 574-372-7567. For questions about recall information contact the Manager of Customer Quality 574-372-7333.

Device

Device Recall Pinnacle
  • Modèle / numéro de série
    product code1221-36-452, lot 187460.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.
  • Description du dispositif
    Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 || Product Usage: || An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA