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

Recall Z-1285-2013 — DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel

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-1285-2013
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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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