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Type of Product	Biological
TGA Recall Reference	RC-2023-RN-00119-1
Product Name/Description	Grafton DBM products: Grafton Putty, Grafton Crunch, Grafton Flex, Grafton Orthoblend, Grafton Matrix, Grafton Matrix Strips, Grafton Plus Paste, Grafton DBF, Grafton DBF Inject, Accelerate Grafton DBF, Grafton Gel, XPANSE Bone Insert ARTGs: 229633, 229634, 229635 and 229636
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/02/2023
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic identified during the packaging process that some seals on the outermost Tyvek pouch sterile barrier for Grafton product did not conform to Medtronic’s specifications. During rework of affected part codes within Medtronic’s control, some units inspected exhibited an incorrect packaging configuration with rolled inner foil packaging. Medtronic’s investigation indicates that non-conforming packaging may have escaped detection and been released.
Recall Action	Recall
Recall Action Instructions	Medtronic ask customers to Identify and quarantine any unused impacted product(s). In addition the following website can also be used to determine if specific product serial numbers are impacted: https://www.medtronic.com/graftonrecall. The website will be updated regularly. There are no actions required for patients where the affected products were used during a procedure. These patients should continue to be monitored as usual in accordance with standard care protocols.
Contact Information	0421083104 - David Hamilton