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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