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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01092-1
Product Name/Description Trinica Ratchet Handles (included in the Anterior Lumbar Plate (ALP) Instrument Tray)

Part Number: 07.00438.001

Instrument Tray Part Number: 07.01058.001

ARTG Number: 179397
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 24/10/2013
Responsible Entity Zimmer Pty Ltd
Reason/Issue The ratchet handles may not be effectively sterilised if left in their designated locations in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle.
Recall Action Recall for Product Correction
Recall Action Instructions Zimmer is advising users to sterilise the Ratchet Handles externally to the instrument tray. Replacement trays are currently being designed and will be available by July 2014.
Contact Information 1800 803 263 - Zimmer Customer Service