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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00600-1
Product Name/Description	MENTOR Gel Sizers (Sizer for mammary prosthesis) Product Code: RSZ5501 Lot Number: 6680501 Product Code: RSZ2751 Lot Number: 6749298 ARTG Number: 157489
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/06/2014
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	A complaint was received for a volume discrepancy between the pad print (500cc) and laser engraved marking and all other product labelling (550cc) on a MENTOR Gel Sizer manufactured at Mentor Leiden. During the bounding investigation, a second lot was identified as having a style discrepancy between pad print (Moderate Profile, MP) and all other product labelling (Moderate Plus, M+). Misjudging the size or style of an implant can result in asymmetric outcome, which may need additional surgery.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical (JJM) is requesting their customers to quarantine the affected stock immediately. Arrangements to return the product can be made by contacting the JJM customer service.
Contact Information	1800 338 160 - Johnson & Johnson Medical Customer Service