Recall Z-2777-2016— Integra LifeSciences Corporation

Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2016-03-11, terminated 2016-09-13. FDA's recall record names no specific 510(k) clearance for this event. 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 treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient Manufactured by: Integra LifeSciences Corporation 311 Enterprise Drive, Plainsboro, NJ 08536 877-444-1122 USA n 609-936-5400 outside USA 866-800-7742 fax. Reason: 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)..

Recalling firm

Integra LifeSciences Corporation

Classification

Class II

Status

Terminated

Initiated

2016-03-11

Terminated

2016-09-13

Firm location

Plainsboro, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.