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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