Events

Recall of Device Recall Newdeal Qwix Fixation Screw

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

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
    47244
  • Event Risk Class
    Class 2
  • Event Number
    Z-1445-2008
  • Event Initiated Date
    2008-02-27
  • Event Date Posted
    2008-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69092
  • 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
    Bone Fixation Screw - Product Code HWC
  • Reason
    Certain qwix fixation screws (reference numbers 111426s and 111428s) have been etched and labelled with an incorrect length.
  • Action
    Integra Reps were sent recall notification with a recall acknowledgement on 2/27/2008. The customers who were shipped affected product were also notified on that date.

Device

Device Recall Newdeal Qwix Fixation Screw
  • Model / Serial
    Catalog number: 111426S; Lot E54Q
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of NC, IL, CA, NC and TX.
  • Product Description
    QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.