| 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 |
|
| 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 |