Events

Recall of Brennen Skin Graft Mesher

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Molnlycke Health Care, Inc.

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
    77121
  • Event Risk Class
    Class 2
  • Event Number
    Z-2110-2017
  • Event Initiated Date
    2017-04-24
  • Event Date Posted
    2017-05-03
  • 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=154993
  • 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
    Expander, surgical, skin graft - Product Code FZW
  • Reason
    Sterilization validation failure.
  • Action
    Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.

Device

Brennen Skin Graft Mesher
  • Model / Serial
    Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.
  • Product Description
    Brennen Skin Graft Mesher. || Surgical instrument designed to expand skin grafts'
  • Manufacturer
    Molnlycke Health Care, Inc

Manufacturer

Molnlycke Health Care, Inc
  • Manufacturer Address
    Molnlycke Health Care, Inc, 5550 Peachtree Pkwy Ste 500, Norcross GA 30092-2555
  • Manufacturer Parent Company (2017)
    Investor AB
  • Source
    USFDA