Events

Recall of Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm 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
    74114
  • Event Risk Class
    Class 2
  • Event Number
    Z-1965-2016
  • Event Initiated Date
    2016-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146323
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    As a result of an internal investigation of a non-conformance it has been determined: 1) depth gauges from lot up15h2 exceed the overall length specification requirements. 2) depth gauges from prior lot numbers manufactured before integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. the number should be 4, it is 6. 3) the space / holder.
  • Action
    The firm, Integra Lifesciences, sent an "Urgent: Voluntary Medical Device Recall" letter dated 5/10/16 to affected consignees/customers via traceable courier service on 5/10/16. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using and distributing product immediately; complete and return the Recall Acknowledgement and Return Form via fax to 1-609-275-9445 or email to FCA2@integralife.com, even if you do not have any of the product. Should you have any questions, please contact Customer Service at 1-866-854-8300.

Device

Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws
  • Model / Serial
    Lot UP15H2, Lot UP09D3, Lot UP07E2
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
  • Product Description
    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws || The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.