Events

Recall of Device Recall NEO(R) NonLocking screws

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
    77781
  • Event Risk Class
    Class 2
  • Event Number
    Z-2869-2017
  • Event Initiated Date
    2017-07-13
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157865
  • 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
    The firm received several customer complaints reporting some perioperative breakages of ne0411 non-locking screws when inserting the screw into the radius diaphysis.
  • Action
    In2Bones sent a Field Safety Corrective Action letter dated July 13, 2017, to all affected customers. The consignee was directed to remove the products from distribution and return it to the recalling firm. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +337 61 88 44 30 or by email: qualite@in2bones.com.

Device

Device Recall NEO(R) NonLocking screws
  • Model / Serial
    All batch numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
  • Product Description
    Non-Locking screws in the following lengths: || (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 || (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 || (c) DRP 0.27 - 12 mm, REF W27 ST012 || (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 || (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 || (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 || (f) DRP 0.27 - 18 mm, REF W27 ST018 || The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy
  • 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