Integra LifeSciences Corporation Recall: Integra Meshed Dermal Regeneration Template 5 cmx
Integra LifeSciences Corporation Recall: Integra Meshed Dermal Regeneration Template 5 cmx is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Integra LifeSciences Corporation; Product: Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regen
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Product | 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 and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatm |
| Reason for recall | 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution to PA |
| Recall initiated | 20160311 |
| Recall number | Z-2777-2016 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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