Events

Recall of Integra Ruggles Surgical Instrument ACF Distraction Screws

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
    50112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0854-2009
  • Event Initiated Date
    2008-10-22
  • Event Date Posted
    2009-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74754
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.
  • Action
    Urgent: Product Recall Notification letters were sent via Fed Ex on October 22, 2008. The letter asked customers to quarantine any of the affected stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Customers were to fill out the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified in the letter. Additional questions can be directed to Christin Roach at 609-936-5413. A Urgent: Product Recall Second Notification dated 1/5/2009 was sent to customers providing them with additional information on the packaging error and included immediate and/or product used during surgery. This notification also requested that all surgeons be notified who were or may have been provided with any of the screws affected by this recall.

Device

Integra Ruggles Surgical Instrument ACF Distraction Screws
  • Model / Serial
    lot code 326081; and lot code 327081.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Integra Ruggles Surgical Instrument ACF Distraction Screws || Sterile, Rx only || Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), || Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.