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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00151-1
Product Name/Description	DePuy CMW 2 Gentamicin Bone Cement 20 g Part Number: 3325020 Lot Numbers: 3590475, 3607803, 3620321 and 3625505
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	13/02/2014
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	The amount of gentamicin detailed on the unit outer carton label is incorrectly stated as 1.0 M.I.U. (Million International Units). This should be labelled 0.5 M.I.U. Information on the foil pouch and IFU is correct. The composition of the mislabelled bone cement complies with the product specifications and the cement functions according to design intent. The affected lots should be used in the normal manner in accordance with the IFU, and the gentamicin content on the outer carton label for these batches should be disregarded.
Recall Action	Recall for Product Correction
Recall Action Instructions	Johnson & Johnson Medical are advising users to continue to follow the Instructions for Use (IFU).
Contact Information	1300 562 711 - Johnson & Johnson Medical Customer Service