| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00897-1 |
| Product Name/Description |
Sterile K-Wire and Steinmann Pin Products (Typically used for temporary fixation of bones in the extremities)
Multiple part and lot numbers affected
ARTG number: 131082 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Sterile K-Wire and Steinmann Pin products are being recalled due to a packaging issue. Specifically, there is a concern with the inner sterile pouch sealing of the product that may constitute a breach of the sterile barrier. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew is advising users to inspect stock for affected product. Any affected product will be replaced by Smith & Nephew. |
| Contact Information |
02 9857 3917 - Smith & Nephew Regulatory Affairs |