Events

Recall of Device Recall TITAN

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
    79597
  • Event Risk Class
    Class 2
  • Event Number
    Z-1463-2018
  • Event Initiated Date
    2017-12-20
  • Event Date Posted
    2018-04-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162744
  • 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
    Template - Product Code HWT
  • Reason
    Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. all cases resulted in a delay in surgery, with a variance of medical intervention required.
  • Action
    Firm sent letters to consignees on December 20, 2017. Firm asked consignees to examine inventory and determine if consignee had affected product. Firm promised to send new stem trials along with a return shipping label. Firm asked to complete the Acknowledgment and Return Form and email or fax back to firm. For further questions, please call (609) 275-0500.

Device

Device Recall TITAN
  • Model / Serial
    TRL092002506  Lot Numbers: 19419-1 15916-1 15457-1 201274-1 201893-1 2046177  TRL092002507 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178  TRL092002508 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179  TRL092002509 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710  TRL092002510 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711  TRL092002511 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712  TRL092002512  Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713  TRL092002513 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714  TRL092002514  Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715  TRL092002515 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716  TRL092002516 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution.
  • Product Description
    The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: || Catalog Number Product Description || TRL092002506 Humeral Stem Trial, 6mm || TRL092002507 Humeral Stem Trial, 7mm || TRL092002508 Humeral Stem Trial, 8mm || TRL092002509 Humeral Stem Trial, 9mm || TRL092002510 Humeral Stem Trial, 10mm || TRL092002511 Humeral Stem Trial, 11mm || TRL092002512 Humeral Stem Trial, 12mm || TRL092002513 Humeral Stem Trial, 13mm || TRL092002514 Humeral Stem Trial, 14mm || TRL092002515 Humeral Stem Trial, 15mm || TRL092002516 Humeral Stem Trial, 16mm
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.