Events

Rappel de Device Recall DRP SCREW

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 In2Bones, SAS.

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
    76104
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0952-2017
  • Date de mise en oeuvre de l'événement
    2016-12-19
  • Date de publication de l'événement
    2017-01-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152163
  • 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
    Dimensional non-conformity of the thread on the screw head.
  • Action
    IN2BONES en a Field Safety Corrective Action letter dated December 15, 2016, to the sole US distributor. The letter identified the product, the problem, and the action to be taken by the customer. We therefore recommend you to follow the instructions here below: 1. Identify all the devices with the batches subject of this recall that might still be in your inventory and quarantine them 2. Inform and distribute this Recall Notification to all relevant persons within your organization 3. To distributors only: Identify all the devices with the batches subject of this recall that were delivered to your customers, and if relevant, instruct them to also follow these instructions (identification and quarantine) 4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to comply with the recommendations listed. This fax back form will enable In2Bones to conduct effectiveness checks. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at +33 4 72 29 26 26 / +33 7 61 88 44 30 or by email: qualte@in2bones.com. For questions regarding this recall call 844-602-6637.

Device

Device Recall DRP SCREW
  • Modèle / numéro de série
    Lot Numbers: a) 1602064, b) 1606067
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US TN only and Internationally to France and Switzerland
  • Description du dispositif
    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France || The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
  • Manufacturer
    In2Bones, SAS

Manufacturer

In2Bones, SAS
  • Adresse du fabricant
    In2Bones, SAS, 28 Chemin du petit Bois, Ecully France
  • Société-mère du fabricant (2017)
    In2Bones SAS
  • Source
    USFDA