| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01019-1 |
| Product Name/Description |
Triathlon MIS Modular Distal Capture
(optional tool which can be attached to the distal resection guide to complete the cut)
Part Number: 6541-5-723
Lot Numbers: AF1C11, AF1C11M, AF1E01D, AF1E01MX3, AF1T43, AF8V03
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has received customer complaints regarding the Triathlon MIS Modular Distal Capture device disassociating during use.
This may result in one or more of the following potential patient harms:
· Complications associated with extended surgery time
· Inflammation / inflammatory response.
· Revision surgery to retrieve loose spring. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect stock and quarantine any affected units. Affected units will be replaced with unaffected stock. This action has beem closed-out on 05/12/2016. |
| Contact Information |
1800 803 601 - Stryker Australia |