FDA-Device2013-05-22Class II
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
Integra LifeSciences Corporation
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.
Sold states
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.
Affected count
215 boxes
Manufactured in
105 Morgan Ln, Plainsboro, NJ, United States
Products
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2013Don't want to check this manually?
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