| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01469-1 |
| Product Name/Description |
K-Wires for T2 and Gamma Systems (Internal fixation wire)
GAM Kirschner Wire
Item Number: 12106450S
T2 K-Wire
Item Number: 18060050S
T2 K-Wire Recon
Item Number: 18063030S
Multiple Lot Numbers affected
ARTG Number: 143230 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Through a review of packaging, Stryker has identified that the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch may not be sealed at one end due to a manufacturing error. A missing seal could potentially lead to unsterile product. Risk mitigating factors include that the non-conformance is obvious to the user. Surgical guidelines outline inspection of the sterile barrier (seal) for sterile packed medical devices prior to use. The pouch itself shows a note: “Contents sterile unless this package has been damaged or opened.” The secondary packaging is a (plastic) clear tube with silicone caps at both ends. While not validated as a sterile barrier, it does provide additional protection to the enclosed pouch package configuration.
No injury or harm has been reported regarding this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect their inventory for affected products and quarantine any affected items immediately. A Stryker representative will coordinate the return of any affected product and supply unaffected ones where necessary. This action has been closed-out on 28/06/2017. |
| Contact Information |
02 9467 1175 - Stryker Recall Specialist |