Home / Recalls / Integra LifeSciences Corporation / Z-1300-2013

Z-1300-2013 Class II Terminated

Recalled by Integra LifeSciences Corporation — Plainsboro, NJ

Recall Details

Product Type
Devices
Report Date
May 22, 2013
Initiation Date
March 28, 2013
Termination Date
June 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
215 boxes

Product Description

Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

1125812 1125816 1126021

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