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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00354-1
Product Name/Description Nitinol Staples

Elastic Staples - Large and Small Symmetrical

Multiple Model and Lot Numbers

Panel Code: 87 Orthopedic, Part 888.3030

Product Code: JDR

All staples manufactured between March 12, 2015 - present

ARTG Number: 229705
(LMT Surgical - Fixation device, internal, staple)
Recall Action Level Wholesale
Recall Action Classification Class II
Recall Action Commencement Date 26/04/2018
Responsible Entity LMT Surgical Pty Ltd
Reason/Issue During a retrospective review of sterilisation records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the relevant regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose and although TriMed has not received any reports of adverse events or injuries, there is a risk that this issue could result in patient infection if not properly sterilised.
Recall Action Recall
Recall Action Instructions As a permanent corrective action, TriMed will recall all of the Nitinol Staples that were manufactured between March 12, 2015 to the present date.

This action has been closed out on the 16/11/2018.
Contact Information 07 3367 6600 - LMT Surgical