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Recall Observatory FDA recall evidence

Device 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.

Z-1300-2013

March 28, 2013

Class II

Product summary

Firm
Integra LifeSciences Corporation
Event
Event 64778
Status
Terminated
Classification
Class II
Quantity
215 boxes
Official record key
device-enforcement:Z-1300-2013

Official wording

Reason: 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.

Code information: 1125812 1125816 1126021

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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    process deviation