Integra LifeSciences Corporation recalls DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and r

Recalled May 22, 2013 · FDA recall Z-1284-2013 · Integra LifeSciences

Hazard

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. · FDA Class II

Units

21,179 boxes

Sold at

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Description

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Product

DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

Manufacturer(s)

Integra LifeSciences Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →