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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00102-1
Product Name/Description	LCP Distal Tibial Plates 3.5 anterolateral, left, 9 holes, length 132mm Stainless Steel Sterile Part Number: 241.445S Lot Number: 8361311 ARTG Number: 157069
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/01/2016
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	It has been discovered that the outer packaging and the inner pouch of affected part and lot numbers may not be sealed; thus the implant are potentially not sterile. Infection and adverse tissue reaction may occur if the plate is implanted despite unsealed peel pouches.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical (JJM) is advising users to inspect stock and quarantine any affected units. Affected stock can be returned to JJM.
Contact Information	1300 562 711 - JJM Customer Service