Events

Rappel de DePuy Spine

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 Spine, 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
    75454
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0628-2017
  • Date de mise en oeuvre de l'événement
    2016-10-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-09-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150411
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Cause
    Skyline variable ti screws may have contained skyline constrained ti screws within the packaging.
  • Action
    The firm, DePuy Synthes Spine, sent an "URGENT! VOLUNTARY PRODUCT CORRECTION NOTIFICATION" letter dated 10/12/2016 to its Customers. Sales consultants supporting these customers received an email notification with required reply forms. The letter described the product, problem and actions to be taken. A DePuy Synthes Spine Sales consultant has been notified and will be reviewing inventory to ensure correct screw placement within your set. The customers were instructed to review, complete, sign and return the attached business reply form to DePuy Synthes Spine via email to: DPYUS-SpineFieldActions@its.jnj.com within 5 business days of receipt of this notification; forward the notice to anyone in your facility that needs to be informed; if devices have been forwarded to another facility, contact that facility and provide them with notice, and keep a copy of the notice. Questions about this recall, please contact Recall Coordinator, DePuy Synthes Spine (via telephone: 508.828.3647 or via email: DPYUS- SpineFieldActions@its.jnj.com).

Device

DePuy Spine
  • Modèle / numéro de série
    Lot Codes: AFFBMZ AFN6D5 AMMDVJ
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
  • Description du dispositif
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm || Item Code: 186854018 || The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Adresse du fabricant
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA