| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01343-1 |
| Product Name/Description |
Triathlon Tibial Alignment Ankle Clamp EM
Catalogue Number: 65412609
Lot Numbers: Lots prior to X9L06
Affected Kits: 65418002-T, 65418030-T, TRIAR36PREP-T, WKSHP65418002-T & SHAPECONV-T
ARTG number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Stryker Orthopaedics carried out a recall for product correction in July 2013 (RC-2013-RN-00699-1) due to complaints associated with cracks or fracture of the Plastic Triathlon Tibial Alignment Ankle Clamp (old design). This issue may lead to potential complications during Surgery in the event a replacement sterile ankle clamp is required mid-procedure, which may create a delay exceeding 30 minutes in duration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This action has been closed-out on 05/12/2016. |
| Contact Information |
02 9467 1000 - Stryker Australia |