Events

Rappel de Device Recall USS Small Stature

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 Synthes USA HQ, 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
    65563
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1935-2013
  • Date de mise en oeuvre de l'événement
    2013-06-05
  • Date de publication de l'événement
    2013-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119580
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Cause
    Depuy synthes has issued a medical device correction notice for the 5.0mm stainless steel rods. this product was produced using a finishing process not identified as part of the manufacturing specification. no adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t.
  • Action
    On June 5, 2013, De Puy Synthes notified by letter the direct acc acccounts which were identified to have received 5.0mm stainless steel rods and requested return of the product by calling 1-800-479-6329 to obtain a return authorization number. Completion of the verification section of the letter, including negative responses was also requested.

Device

Device Recall USS Small Stature
  • Modèle / numéro de série
    Part Numbers: 298.269 298.270 298.271 298.272 298.273 298.274 298.275 298.276 298.277 298.278  with lot numbers:  4729951; 4841209; 4923651; 4923652; 4987688; 4987750; 5350635; 2002330; 3000595 4729952; 4841210; 4923653; 4923654; 4987683; 4856248; 4987755; 5153848; 5153853; 1602596; 1880489 4729953; 4841211; 4923666; 4923667; 4987778; 4856275; 4987761; 5159826; 5157329; 3016224  4729954; 4841212; 4919162; 4923669; 4987779; 4856250; 4987766; 5153796; 3093619 4729956; 4923674; 4987825; 4987780; 5066363 4729958; 4923615; 4987826; 4987781; 5066364 4729959; 4841213; 4923655; 4936270; 4987684; 4987771; 5153849; 5153854 4729960; 4835367; 4923656; 4923657; 4984982; 4856246; 4987772; 5159827; 5157330  4729961; 4835368; 4923658; 4923659; 4987685; 4856249; 4987773; 1602617; 3080451 4729962; 4835378; 4919165; 4923660; 4987686; 4856252; 4987776; 5153851
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    5.0mm Unit Rod 270mm || 5.0mm Unit Rod 290mm || 5.0mm Unit Rod 310mm || 5.0mm Unit Rod 330mm || 5.0mm Unit Rod 350mm || 5.0mm Unit Rod 370mm || 5.0mm Unit Rod 390mm || 5.0mm Unit Rod 410mm || 5.0mm Unit Rod 430mm || 5.0mm Unit Rod 450mm || pedicle screw spinal system; || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • Adresse du fabricant
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA