| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01151-1 |
| Product Name/Description |
Teflon Tube T2 Humerus, Sterile (Intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires for nail insertion)
Catalogue Number: 18060073S
Lot Number: K0432D3
ARTG Number: 139623 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has become aware that certain lots of the Teflon Tube have demonstrated a deficient seam in the sterile packaging. There is the potential for the inner pouch to be unsterile due to missing seal integrity. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is requesting hospitals to inspect their stock to determine if they have units from the affected lots. All affected product is to be returned to Stryker. |
| Contact Information |
1800 803 601 - Stryker Regulatory Affairs/Quality Assurance |