Urgent Voluntary Recall of Integra LifeSciences DuraGen Plus Adhesion Barrier Matrix, DuraGen Dural Graft Matrix and Suturable DuraGen Dural Regeneration Matrix

Integra LifeSciences is voluntarily recalling specific lots of DuraGen Plus Adhesion Barrier Matrix, DuraGen Dural Graft Matrix and Suturable DuraGen Dural Regeneration Matrix. Due to deviation from the manufacturing process, products may have been released with higher levels of endotoxins than permitted by the product specifications. Higher endotoxin levels may result in a fever in the immediate postoperative period. DuraGen Plus Adhesion Barrier matrix is indicated for use as an onlay graft for the repair and restoration of dural defects in cranial and spinal surgical procedures. It is also indicated as an adhesion barrier for the inhibition of post-surgical peridural fibrosis and may be used to close dural defects following traumatic injury, excision, retraction or shrinkage. It may be used to supplement primary closure. Please refer to the Dear Healthcare Professional Letter for more details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.