Events

Recall of Device Recall Qwix 4.3mm Stabilization Screws 34mm

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

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
    54618
  • Event Risk Class
    Class 2
  • Event Number
    Z-1254-2010
  • Event Initiated Date
    2010-02-08
  • Event Date Posted
    2010-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89804
  • 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
    The screws were etched incorrectly as 32mm instead of the correct 34mm length.
  • Action
    Consignees were notified via conference calls and/or FedEx mailing. Recall aknowledgement forms were provided with written notification. This requires consignees to review their inventory and to indicate any affected lots . This form requires a signature and must be returned.

Device

Device Recall Qwix 4.3mm Stabilization Screws 34mm
  • Model / Serial
    Part Number: 111434SND  Lot Number: E6DO
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.
  • Product Description
    Qwix 4.3mm Stabilization Screws - 34mm
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation