Events

Rappel de Device Recall 6hole Pubic Symphysis plate

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 Acumed LLC.

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
    76332
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1199-2017
  • Date de mise en oeuvre de l'événement
    2017-01-19
  • Date de publication de l'événement
    2017-02-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152823
  • 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
    Plate, fixation, bone - Product Code HRS
  • Cause
    The 6-hole pubic symphysis plate (pn 70-0451) is specified to be made of commercially pure titanium (astm f67 - cp grade 4). however, batch 383813 was manufactured out of titanium alloy (ti-6al- 4v eli per astm f135  ti alloy) and was distributed.
  • Action
    Acumed sent an Urgent Medical Device Recall letter dated January 16, 2017, to all affected customers on January 19, 2017. Consignees were instructed to follow special instructions and send survey to RecallNotification@acumed.net. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email AgentInventory@acumed.net to obtain a Return Material Authorization (RMA) number or contact your agent directly. International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at BusinessServices@acumed.net or via phone 877-627-9957, choose Option 4 (US and Canada), or call 001-503-627-9957, choose option 4 (outside of US and Canada) have to obtain a Return Material Authorization (RMA) number.

Device

Device Recall 6hole Pubic Symphysis plate
  • Modèle / numéro de série
    Lot number: 383813
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
  • Description du dispositif
    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with || 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. || The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Adresse du fabricant
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Société-mère du fabricant (2017)
    Acumed Llc
  • Source
    USFDA