Events

Recall of Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System)

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-2018-RN-00280-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00280-1
  • 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 a report that a hinge pin disassociated from the mako onlay insert extractor. in that reported case, the disassociated hinge pin was discovered prior to the device being used in surgery and a backup device was available and subsequently used to complete the procedure. in the event of an undetected disassociated hinge pin, the potential hazards include the hinge pin being left in the wound or excessive metal wear giving rise to debris. to date, there have been no injuries reported as a result of this issue.
  • Action
    Stryker is advising users to inspect stock and return any remaining units of the affected lot numbers.

Device

Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System)
  • Model / Serial
    Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System)Item Number: 160430Lot Numbers: 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016,19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26130512, 26170513, 26201111, 26290412, 26440912ARTG Number: 223107
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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