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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 Stryker Australia Pty Ltd
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