| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00682-1 |
| Product Name/Description |
QuikFlap Neuro Implants
Multiple Item Numbers
Multiple Lot Numbers
ARTG Number: 295882
(Stryker Australia - Cranofacial fixation plate, non-biodegradable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
The current packaging and IFU indicate a five-year shelf life. During long-term product testing, it was discovered that after a three-year term, there is a potential for the external packaging (sterile barrier) to become compromised. Such compromised packaging results in the loss of the vacuum seal allowing for contamination of the inside peel pouch. A breach of the outer peel pouch has only been observed with packages at shelf life end and after excessive transportation testing.
To date, Medtronic have not received any complaints as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising customers to quarantine affected stock to prevent further use. Stryker representatives will contact customers to help coordinate the return of any affected product.
In the event this device has been recently implanted, surgeons are advised to monitor for signs of infection as per their normal processes.
This action has been closed out on the 16/10/2018. |
| Contact Information |
02 9467 1175 - Stryker |