Events

Recall of Optipac Bone Cement

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-2016-RN-01539-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01539-1
  • 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
    Through an internal investigation biomet orthopaedics has identified that the sterilisation process for optipac bone cement cannot be guaranteed to be fully compliant. the most probable potential risks related to this sterilisation issue include:- inflammation- pain- early infection- potential swelling around the jointbiomet orthopaedics conducted a review of complaints for the optipac and the reported rate for infections was 0.0004 %.
  • Action
    Zimmer Biomet is advising customers to immediately locate and remove affected devices, and then return these devices to Zimmer Biomet who will issue credit for returned stock. Zimmer is advising that, based on the current information, there does not appear to be a need for additional patient follow-up beyond the standard patient follow-up. This action has been closed-out on 25/05/2017.

Device

Optipac Bone Cement
  • Model / Serial
    Optipac Bone CementOptipac 40 Refobacin Plus Bone CementOptipac 60 Refobacin Plus Bone CementOptipac 80 Refobacin Plus Bone CementOptipac-S 40 Refobacin Plus Bone CementOptipac-S 60 Refobacin Plus Bone CementOptipac-S 80 Refobacin Plus Bone CementAll sizes manufactured since January 2014Multiple Material and Batch NumbersARTG Number: 168753
  • 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