Events

Recall of Device Recall INSTAT

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
    64778
  • Event Risk Class
    Class 2
  • Event Number
    Z-1288-2013
  • Event Initiated Date
    2013-03-28
  • Event Date Posted
    2013-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117045
  • 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
    Agent, absorbable hemostatic, collagen based - Product Code LMF
  • Reason
    Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
  • Action
    The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: FCA@integralife.com or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.

Device

Device Recall INSTAT
  • Model / Serial
    1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
  • Product Description
    INSTAT - Agent, Absorbable Hemostatic, Collagen Based || INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation