Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1300-2013 — Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.

U.S. FDA — Device Enforcement · United States · 2013-03-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1300-2013
Date of alert
2013-03-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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