Events

Recall of Device Recall Integra Mosaik Putty

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
    50899
  • Event Risk Class
    Class 2
  • Event Number
    Z-1034-2009
  • Event Initiated Date
    2009-01-16
  • Event Date Posted
    2009-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77620
  • 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
    Calcium Bone Void Filler Compound - Product Code MQV
  • Reason
    Potential for open seals in the inner foil pouch of certain products. the outer seal remains intact and therefore the sterility of the inner pouch is maintained.
  • Action
    Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.

Device

Device Recall Integra Mosaik Putty
  • Model / Serial
    Lot codes: 105B00135019, 105B00135020, 105B00135021, and 105B00135022.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.
  • Product Description
    Integra Mosaik Putty, 15cc, Catalog # PTY10256 || Integra Lifesciences, Plainsboro, NJ
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp