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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00352-1
Product Name/Description	DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration) Catalogue Numbers: ID-1101-(I), ID-1105-(I), ID-1301-(I), ID-1305-(I), ID-2201-(I), ID-2205-I, ID-3305-(I), ID-4501-(I), DP-1013-I, DP-1022-I, DP-1033-I, DP-1045-I, DP-1057-I, DURS2291, DURS3391, DURS4591 Multiple lots affected ARTG: 158829, 158825 & 158826
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	22/04/2013
Responsible Entity	Integra Neurosciences Pty Ltd
Reason/Issue	The production process may have deviated during the manufacture of specific lots.The product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. However, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products.
Recall Action	Recall
Recall Action Instructions	Integra is recalling the affected product and is asking clinicans to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol.
Contact Information	1300 550 599 - Integra Customer Service