Events

Recall of Device Recall I.B.S. orthosynthesis 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
    72711
  • Event Risk Class
    Class 2
  • Event Number
    Z-0397-2016
  • Event Initiated Date
    2015-11-18
  • Event Date Posted
    2015-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142015
  • 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
    One batch of osteosynthesis screws were manufactured with the incorrect torx imprint on the screw head.
  • Action
    IN2Bones - USA sent an Field Safety Corrective Action Medical Device Batch Recall letter dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recommended actions : We therefore you to follow the instructions here below: 1. Identify all I.B.screws 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 I.B.screws 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 ln2Bones to conduct effectiveness checks. For any question,plea1se contact our Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +33 7 6188 44 30 or by email:qualite@in2bones.com.

Device

Device Recall I.B.S. orthosynthesis screws
  • Model / Serial
    1509058
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the state of :TN
  • Product Description
    IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
  • 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