Events

Recall of Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures)

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-2016-RN-01468-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01468-1
  • 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 reports of two potential issues related to the offset cup reamer handle. the weld on the u-joint of the handle may become damaged over time, potentially causing the pin or pieces of the pin to fall into the wound. if that occurs, and the surgery proceeds with reaming, the pin or pieces of the pin may fall into the wound, which may be removed if visible or may be left in the wound. the handle also may not fully engage with the registration array and/or reamer basket. if that occurs, the surgery may proceed using a backup offset reamer handle, a straight reamer handle or manual instrumentation.
  • Action
    Customers are advised to inspect their inventory for affected product and quarantine it immediately. A Stryker representative will coordinate the return of any affected products. This action has been closed-out on 28/06/2017.

Device

Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Ace...
  • Model / Serial
    Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures)Item Number: 207080All Lot Numbers affectedContained within trays: 151550, 151550-TARTG Number: 223107
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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