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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00482-1
Product Name/Description	DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit) Part Number: 297500500 Lot Numbers: J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586. NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023 ARTG Number: 191616
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/06/2013
Responsible Entity	Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
Reason/Issue	Johnson & Johnson Medical Pty Ltd (JJM) has identified the potential for the ReClaim Reamer Extension tabs to break off. 9 complaints worldwide since 2011 have been received reporting tab breakage. None of the complaints have indicated fragments were left in patients.
Recall Action	Recall for Product Correction
Recall Action Instructions	JJM is advising that users should check the condition of the reamer extension tabs on a regular basis, especially before and after usage. Any reamer extensions showing signs of cracks in the tab area or having broken or missing tabs, should be returned to JJM. Other devices from the affected lots may continue to be used until a design change is implemented and new devices are available.
Contact Information	02 9815 4000 - Johnson & Johnson Medical