Events

Rappel de PROTHESE A EXPANSION COMPLETE D6 LG 12 MM

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 Wright Medical Technology 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
    63338
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0185-2013
  • Date de mise en oeuvre de l'événement
    2012-09-05
  • Date de publication de l'événement
    2012-10-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113531
  • 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
    There may be inaccuracies on the labeled shelf life on all products packaged at the toulon, france facility.
  • Action
    Wright sent an Urgent Product Recall Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and immediately return to Wright Medical Technology, Inc. Customers were asked to complete and return the enclosed notification form by fax to 901-867-7401. For questions customers should call 901-867-4324. For questions regarding this recall call 901-867-4655.

Device

PROTHESE A EXPANSION COMPLETE D6 LG 12 MM
  • Modèle / numéro de série
    PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
  • Description du dispositif
    Extremity Components: || PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 || PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 || PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 || PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 || TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 || Orthopaedic
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Adresse du fabricant
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002-9501
  • Société-mère du fabricant (2017)
    Wright Medical Group NV
  • Source
    USFDA