Events

Recall of EBI OsteoGen Implantable Bone Growth Stimulator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer Biomet Pty Ltd.

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
    RC-2018-RN-00210-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00210-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Zimmer biomet is conducting a medical device recall for the ebi osteogen implantable bone growth stimulator products due to a lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. the lack of adequate cleaning validation could potentially lead to chemical residuals remaining on the implantable units. the chemical residuals could lead to the potential reactions with patient tissue.
  • Action
    Zimmer Biomet is raising awareness of this issue with implanting surgeons however there are no specific patient monitoring instructions recommended beyond the existing follow-up schedule.

Device

EBI OsteoGen Implantable Bone Growth Stimulator
  • Model / Serial
    EBI OsteoGen Implantable Bone Growth StimulatorItem Number: 10-1320MLot Number: 521632This device supplied via SAS.
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet Pty Ltd
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA