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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00735-1
Product Name/Description Tritanium PL 6mm

Item Numbers:48950066 & 48954066

Lot Numbers: A8AM, A8T2

ARTG Number: 265560
(Stryker Australia Pty Ltd - Spinal cage)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 22/06/2018
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker Australia has discovered that two (2) lots of Tritanium-PL Cages, part number 48950066 (lot # A8AM) and part number 48954066 (lot # A8T2), were shipped and sold to Australia without Market Release Approval. The Tritanium-PL Cage product family has been registered and approved in Australia. However, the specific part numbers 48950066 and 48954066 were not registered in Australia.
Recall Action Recall
Recall Action Instructions Stryker Australia is requesting recipients of the letter to confirm whether they possess any affected stock and to inform any parties who may have received affected stock and to inform Stryker of this using the supplied response forms.
A hazard alert is also being issued.

This action has been closed out on 04/02/2019
Contact Information 02 9467 1175 - Stryker