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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00972-1
Product Name/Description	Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack) Catalogue Numbers: 0932-0-000 (small) and 0932-2-000 (large) Lot Numbers (small): GW281208, GW284192, GW288907, GW282586, GW282310, GW298838, GX303720, GX302994 and GX301732 Lot Numbers (large): GW288908, GW282454 and GW288485 ARTG Number: 140892
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	1/10/2015
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has received a customer complaint which reported that during a total hip replacement the surgeon was using the Exeter small tapered pin reamer when the device fractured approximately 3 inches from the tip. This may result in the tip of the reamer detaching from the instrument. Should this occur and the fragment remain in situ, there are additional potential hazards including excessive metal ions and displacement from MRI.
Recall Action	Recall
Recall Action Instructions	Stryker is advising users to quarantine any affected stock for replacement.
Contact Information	1800 803 601 - Stryker Australia