| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00438-1 |
| Product Name/Description |
Teflon Tube T2 Humerus, Sterile
Catalogue Number: 18060073S
Lot Number: K0432D3
ARTG Number: 139623 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
During a shelf life study, it was found that particular lots of product failed a dye penetration test demonstrating a deficient seam in the sterile packaging.
The seams of the pouches made by one supplier were confirmed to be within specification and do not exhibit any non-conformance. The in-house made cross seam was confirmed to be manufactured out of specification. Thus these lots have been deemed as having potentially insufficient packaging integrity and therefore regarded to be unsterile. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Stryker is notifying surgeons of the issue and provided advice on patient follow up. This action has been closed-out on 04/05/2017 |
| Contact Information |
1800 803 601 - Stryker Australia |