Events

Recall of ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems)

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-2013-RN-01033-1
Event Risk Class
Class II
Event Initiated Date
2013-10-04
Event Country
Australia
Event Source
DHTGA
Event Source URL
https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01033-1
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 complaints associated with cracks and/or fractures of the ball impactor tip and rim impactor tip instruments. the potential hazards include;- cracked or fractured ball impactor tip/rim impactor tip- loose fragments form the ball impactor tip/rim impactor tip- insufficient locking strength of the mdm liner (ball impactor tip only).
Action
Stryker is releasing updated surgical procedures and also updating the loan dockets, recommending the use of a slotted mallet to be used to impact the impactor handle, and emphasising that all tips should be inspected for deformation and cracks before use.

Device

ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant ...

Model / Serial
ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems)ADM/MDM Ball Impactor TipCatalogue Numbers: 12350013 (12350303A-T, 12350306-T, 12350306V-T, 12350306C-T) ADM Rim Impactor TipCatalogue Numbers: 12350014 (12350303A-T)All Lot Numbers AffectedARTG Number: 181721
Manufacturer
Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd

Manufacturer Parent Company (2017)
Stryker
Source
DHTGA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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