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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01038-1
Product Name/Description	Kryptonite Bone Cement / Kryptonite X-Radiopaque Bone Cement (Intended for use as a self-setting bone void filler for bony voids or gaps that are no intrinsic to the stability of the bony structure) Model numbers: KRYP-Z-10 & KRYP-Z-05 All serial numbers and lot numbers produced within the last 18 months ARTG Number: 147863
Recall Action Level	Wholesale
Recall Action Classification	Class III
Recall Action Commencement Date	11/10/2012
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	Several recent modifications have been made to the Instructions for Use including updates to product warnings and storage requirements.
Recall Action	Recall for Product Correction
Recall Action Instructions	The sponsor is providing updated Instructions for Use (IFU) is being provided to the customers.
Contact Information	02 9006 1662 - Emergo Australia