Events

Recall of Device Recall DRP SCREW

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
    76104
  • Event Risk Class
    Class 2
  • Event Number
    Z-0953-2017
  • Event Initiated Date
    2016-12-19
  • Event Date Posted
    2017-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152164
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    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
  • Model / Serial
    Lot Numbers: 1604154, 1605083, 1606068
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US TN only and Internationally to France and Switzerland
  • Product Description
    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, 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
  • Manufacturer Address
    In2Bones, SAS, 28 Chemin du petit Bois, Ecully France
  • Manufacturer Parent Company (2017)
    In2Bones SAS
  • Source
    USFDA