Useful Information

Safety Alert and Recall of Exempted Regulated Product

Recall of GRAFTON® DBM Gel, GRAFTON® DBM Flex, GRAFTON® DBM Putty, GRAFTON® DBM Matrix/ Matrix Strips, GRAFTON® DBM Crunch, GRAFTON® DBM Orthoblend and GRAFTON PLUS® DBM Paste

15 February 2023

The Australian Therapeutic Good Administration (TGA) has posted a recall action notification concerning Grafton DBM products, some of which are exempted regulated products in Hong Kong (see table below).

Exempted Regulated Product	Exemption No. (HK-RPEx No.)
GRAFTON® DBM Gel	2012B-0001
GRAFTON® DBM Flex	2012B-0002
GRAFTON® DBM Putty	2012B-0004
GRAFTON® DBM Matrix/ Matrix Strips	2012B-0005
GRAFTON® DBM Crunch	2012B-0007
GRAFTON® DBM Orthoblend	2012B-0008
GRAFTON PLUS® DBM Paste	2012B-0009

According to TGA, the manufacturer (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.

For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00119-1.

The local exemption holder (Medtronic Hong Kong Medical Limited) initiated a recall for unused affected products in Hong Kong on 14 February 2023 due to an improbable risk of contamination arising from nonconforming packaging issue identified by the manufacturer. Please refer to https://www.medtronic.com/covidien/en-us/products/c/grafton-fca-medical-device-recall.html?cid=URL:MIX:graftonrecall:022023_NS#lotLookupTool for details about this recall. The product replacement in Hong Kong had been completed on 17 March 2023.