Events

Recall of Ethicon MERSILENE Tape

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ethicon 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
    20487
  • Event Initiated Date
    2016-08-11
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Non-ce marked mersilene tape product codes are being supplied with a non-ce marked mersilene suture ifu., mersilene tape and mersilene suture have different indications. mersilene tape is primarily intended for use in, circular suture of the cervix.
  • Action
    Instructions for use to be updated

Device

Ethicon MERSILENE Tape
  • Model / Serial
    Model: RS21 RS22 and D9212, Affected:
  • Manufacturer
    Ethicon Inc

Manufacturer

Ethicon Inc