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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01151-1
Product Name/Description Teflon Tube T2 Humerus, Sterile (Intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires for nail insertion)

Catalogue Number: 18060073S

Lot Number: K0432D3

ARTG Number: 139623
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/11/2013
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker has become aware that certain lots of the Teflon Tube have demonstrated a deficient seam in the sterile packaging. There is the potential for the inner pouch to be unsterile due to missing seal integrity.
Recall Action Recall
Recall Action Instructions Stryker is requesting hospitals to inspect their stock to determine if they have units from the affected lots. All affected product is to be returned to Stryker.
Contact Information 1800 803 601 - Stryker Regulatory Affairs/Quality Assurance