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

Recall Z-2777-2016 — Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen a

U.S. FDA — Device Enforcement · United States · 2016-03-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2777-2016
Date of alert: 2016-03-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Integra LifeSciences Corporation
Product category: device
Product type: Devices

Reported risk: Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750).

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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