Events

Recall of Device Recall SURFIX Fixed Angle Locking Screw

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
    68284
  • Event Risk Class
    Class 2
  • Event Number
    Z-1697-2014
  • Event Initiated Date
    2014-03-28
  • Event Date Posted
    2014-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127268
  • 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
    New deal has identified through a complaint report that some 3.5 mm diameter x 22 mm length surfix screws in lot no. f626 (catalogue no. 285322s) have been packaged and labeled as 3.5mm diameter x 30 mm length surfix screws (catalogue no. 285330s).
  • Action
    Integra issued an Urgent Voluntary Medical Device Recall letter dated March 28, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for affected product, immediately stopo using or distributing them. Customers were asked to complete the Acknowledgement Form and return by email or fax as indicated on the form. When the form is received customer service will contact customers to provide an RMA number and directions to return the affected products. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 609-275-2700.

Device

Device Recall SURFIX Fixed Angle Locking Screw
  • Model / Serial
    SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6;  SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, United Arab Emirates, and United Kingdom.
  • Product Description
    Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation