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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00366-1
Product Name/Description	LCP Distal Femoral Plate 4.5/5.0, right, 19 holes, length 436 mm, Titanium Alloy (TAN), sterile (Orthopaedic fixation plate) Part Number: 04.124.038S Lot Numbers: 3415605, 3443957, 3445554, 3490362, 3490393, 3501330, 3562221, 3585780, 3614924, 3618891, 3618892, 3809489, 3824272, 7557106, 7557107, 7564443, 7564444, 7565993, 7565995, 7574198, 7574199, 7587722, 8174821, 8191379, 8239937, 8300566 ARTG Number: 157069
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	23/04/2013
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	The product description on the six languages label on the back of the box is incorrect in Spanish and Portuguese. Instead of right, the plate is described as being a left plate in these two languages.
Recall Action	Recall
Recall Action Instructions	Synthes is recalling the affected product from the market.
Contact Information	1800 796 8437 - Synthes Customer Service