Events

Recall of Device Recall DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by In2Bones, SAS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70736
  • Event Risk Class
    Class 2
  • Event Number
    Z-1318-2015
  • Event Initiated Date
    2015-03-09
  • Event Date Posted
    2015-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134574
  • Notes / Alerts
    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.
  • Extra notes in the data
    Screw, fixation, bone - Product Code HWC
  • Reason
    Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
  • Action
    The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product.

Device

Device Recall DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002
  • Model / Serial
    Batch numbers: 1404032, 1412011
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the state of TN.
  • Product Description
    DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. || Interphalangeal implant.
  • Manufacturer
    In2Bones, SAS

Manufacturer

In2Bones, SAS
  • Manufacturer Address
    In2Bones, SAS, 28 Chemin Du Petit Bois, Ecully France
  • Manufacturer Parent Company (2017)
    In2Bones SAS
  • Source
    USFDA