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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00438-1
Product Name/Description Teflon Tube T2 Humerus, Sterile

Catalogue Number: 18060073S

Lot Number: K0432D3

ARTG Number: 139623
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 25/05/2015
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue During a shelf life study, it was found that particular lots of product failed a dye penetration test demonstrating a deficient seam in the sterile packaging.

The seams of the pouches made by one supplier were confirmed to be within specification and do not exhibit any non-conformance. The in-house made cross seam was confirmed to be manufactured out of specification. Thus these lots have been deemed as having potentially insufficient packaging integrity and therefore regarded to be unsterile.
Recall Action Hazard Alert
Recall Action Instructions Stryker is notifying surgeons of the issue and provided advice on patient follow up. This action has been closed-out on 04/05/2017
Contact Information 1800 803 601 - Stryker Australia