Events

Rappel de Device Recall DePuy Orthopaedics LCS COMPLETE RPS

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
    71085
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1673-2015
  • Date de mise en oeuvre de l'événement
    2015-03-04
  • Date de publication de l'événement
    2015-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136058
  • 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, metal/polymer, mobile bearing - Product Code NJL
  • Cause
    The lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. if the lcs complete rps knee system is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
  • Action
    On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).

Device

Device Recall DePuy Orthopaedics LCS COMPLETE RPS
  • Modèle / numéro de série
    All Lots. Catalog numbers: 129416110 129416112 129416115 129416117 129416120 129416122 129416125 129416210 129416212 129416215 129416217 129416220 129416222 129416225 129416310 129416312 129416315 129416317 129416320 129416322 129416325 129416410 129416412 129416415 129416417 129416420 129416422 129416425 129416510 129416512 129416515 129416517 129416520 129416522 129416525 129416610 129416612 129416615 129416617 129416620 129416622 129416625 129416710 129416712 129416715 129416717 129416720 129416722 129416725 129417110 129417112 129417115 129417117 129417120 129417122 129417125 129417210 129417212 129417215 129417217 129417220 129417222 129417225 129417310 129417312 129417315 129417317 129417320 129417322 129417325 129417410 129417412 129417415 129417417 129417420 129417422 129417425 129417510 129417512 129417515 129417517 129417520 129417522 129417525 129417610 129417612 129417615 129417617 129417620 129417622 129417625 129417710 129417712 129417715 129417717 129417720 129417722 129417725 129495410 129495412 129495415 129495417 129495420 129495510 129495512 129495515 129495517 129495520 129495610 129495612 129495615 129495617 129495620
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
  • Description du dispositif
    LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
  • 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