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Integra LifeSciences Corporation recalls Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesi
Recalled May 22, 2013 · FDA recall Z-1300-2013 · 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
215 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
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
Manufacturer(s)
Integra LifeSciences Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →