Events

Recall of Skin graft meshers

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Brennen Medical LLC.

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
    21349
  • Event Initiated Date
    2017-05-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Molnlycke Health Care Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Manukau 2022
  • Reason
    The manufacturer has identified a potential safety issue, regarding the current sterilisation validation for the brennen skin graft mesher., phase 2. the manufacturer has completed their validation activities and is now able to provide new sterilisation instructions for the 4.5 (1 1.43 centimeters) devices. these instructions do not apply to the 6.5 brennen skin graft mesher. the manufacturer has also updated their automated and manual cleaning instructions.
  • Action
    Instructions for use to be updated

Device

Skin graft meshers
  • Model / Serial
    Model: , Affected: Brennen Skin Graft Mesher 4.5 Inch, Brennen Skin Graft Mesher 6.5 Inch
  • Manufacturer
    Brennen Medical LLC

Manufacturer

Brennen Medical LLC