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Integra® Dermal Regeneration Template
Integra Lifesciences Corporation · Model 38105 · UDI-DI 10381780000617
0
510(k) clearances
220
Adverse events (55 deaths)
7
Recalls
6
Facilities
Description
INTEGRA Dermal Regeneration Template 8in. x 10in. (20cm x 25cm) 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 a 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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-02-21 | Organogenesis, Inc. | Product sterility may be compromised |
| 2011-01-30 | Organogenesis, Inc. | Product sterility compromised |
| 2010-08-02 | Organogenesis, Inc. | Product is contaminated with a yeast identified as Pseudozyma antarctica. |
| 2009-09-27 | Organogenesis, Inc. | Unit contaminated with Staphylococcus epidermidis |
| 2007-12-26 | Organogenesis, Inc. | Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative r |
| 2006-09-29 | Organogenesis, Inc. | Product pH out of specification |
| 2003-05-02 | Smith and Nephew Wound Management (La Jolla) | Did not meet finished device specifications for the DNA criteria. |
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