| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00620-1 |
| Product Name/Description |
X3 TRIATHLON INSERT CR#2 9MM
Catalogue Number: 5530G209
Lot Number: LEF064
ARTG Number: 216480 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
A customer complaint identified that a Triathlon Tibial Bearing insert CS X3 Size #2 9mm (5531-G-209) was reported to be incorrectly packaged and labelled as a Triathalon CR Size #2 9mm insert (5530-G-209).
Although a delay in surgery of 10 minutes was reported in the complaint, no actual harm was reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are asked to inspect stock on hand and quarantine any affected units. This action has been closed-out on 05/09/2016. |
| Contact Information |
02 9467 1052 |