Events

Rappel de ENDOFUSE(R) Fusion Rods

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
    58717
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2589-2011
  • Date de mise en oeuvre de l'événement
    2011-04-20
  • Date de publication de l'événement
    2011-06-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100138
  • 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
    Screw, fixation, bone - Product Code HWC
  • Cause
    Two lots- one lot of endo-fuse fusion rod, 7x50mm was commingled one lot of endo-fuse(r) fusion rod, 7x70mm. not all parts in each lot are affected. the commingled rod sizes might not be detected prior to surgery.
  • Action
    The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401. If you have any questions regarding this matter, please contact 800-874-5630.

Device

ENDOFUSE(R) Fusion Rods
  • Modèle / numéro de série
    Lot Number 088605355, Reference #500005950
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, ID, IN, IL, LA, MI, MN, MO, NC, NE, NH, NY, OH, PA, SC, TN, TX, VA, VT, WA, and WI.
  • Description du dispositif
    ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355, || IMPLANT MATERIAL: Wright Medical Technology, Inc , 5677 Airline Road, Arlington, TN 38002 || The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
  • 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