Events

Recall of METS Principal Shaft

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-01412-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01412-1
  • 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 initiated a lot specific hazard alert. the mets product family of components are double pouched in polyamide/polyethylene (pa/pe) material and a box. during inspection, certain mets principal shafts were found to be missing the outer pouch. upon review, two additional principal shafts from the same lot were also discovered to be missing an outer pouch.
  • Action
    Patients implanted with an affected lot number of the METS Principal Shaft should continue to be followed per the normal protocol established by his/her surgeon. Inform users of this Hazard Alert and forward this notice to all those individuals who need to be aware within your organisation. Complete the “Hazard Alert Notification Response” form, and return the form to Stryker electronically by email as directed.

Device

METS Principal Shaft
  • Model / Serial
    METS Principal ShaftItem Number - msfshaft/150Lot Number - B10562ARTG Number: 246516 (Stryker Australia Pty Ltd - Femur/tibia shaft prosthesis)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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