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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00659-1
Product Name/Description Specialty Size 33mm Reduced Diameter Reaming Cutter

Catalogue Number: I-K0913DC33

All lots affected

ARTG Number: 140892
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/05/2016
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker has discovered that the Specialty 33mm Cutter outer diameter was designed too large and would thus prevent the device from passing through the Specialty Clamping Barrel.
This may result in the surgery time being extended by up to 15 minutes to retrieve and use an alternative readily available instrument.
Recall Action Recall
Recall Action Instructions Stryker is advising customers to inspect stocks and quarantine any affected units prior to their return to Stryker. This action has been closed-out on 03/02/2017.
Contact Information 02 9467 1175 - Stryker