Events

Recall of JTS Drive Unit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia 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-2017-RN-00865-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00865-1
  • 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
    Stryker has received three complaints regarding the jts drive unit. these relate to the potential for utilisation of the jts grower drive in the incorrect orientation in relation to the limb entry point of the device and the potential to select incorrect settings for the extension procedure. as a result, the prostheses in such cases failed to extend as intended.New labelling is to be provided, and a quick start guide attached to the device, along with revisions to the limb lengthening protocol & operation manual to reference these labelling modifications. these modifications/ updates are to clarify the correct orientation in relation to the limb entry point of the device.
  • Action
    Stryker is requesting: 1. Users of this Medical Device forward the supplied notice to all those individuals who need to be aware within their organisation; 2. Inspect inventory for the impacted JTS Drive Unit and quarantine it immediately; 3. Contact their local Stryker representative to coordinate the return of any affected product you may have; 4. Complete the supplied “Medical Device Recall Notification Response” form even if they do not have any affected product. Return the form to Stryker by fax on (02) 9467 1325 or electronically via email to recalls@stryker.com; 5. If any affected stock could have been transferred from their hospital to another location, please immediately let them know of this recall and notify Stryker 6. If customers have disposed of any affected units, provide the item and lot numbers of the disposed product to Stryker via email account recalls@stryker.com.

Device

JTS Drive Unit

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA