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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00020-1
Product Name/Description	Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device) Product Code: UFPS-133057 Lot Numbers: 817101080, 8081106264 Product Code: UFPS-133058 Lot Numbers: 8191203108, 8191206116, 8191208096, 8191211137, 8191305131, 8191309178 Product Code: UFPS-145058 Lot Numbers: 8301012171, 4871304081, 830100357 ARTG Number: 169175
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/01/2014
Responsible Entity	Matrix Surgical Pty Ltd
Reason/Issue	This is a follow up to an earlier recall (TGA Reference: RC-2012-RN-00637-3) where the insulation of a diathermy spatula appeared to have melted during use and that the patient sustained secondary site damage to their fallopian tube. The manufacturer has determined that the safest maximum operating level for the diathermy spatulas is 30 watts.
Recall Action	Recall
Recall Action Instructions	Matrix Surgical is advising users to quarantine affected stock for return to Matrix Surgical for replacement or credit note. Updated Instructions for Use (IFU) will be provided to all users along with the newly supplied devices. This action has been closed-out on 11/02/2016.
Contact Information	1300 616 366