BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2777-2016 · Initiated March 11, 2016

    Recall

    Recall Number
    Z-2777-2016
    Event Number
    73689
    Firm
    Integra LifeSciences Corporation
    FEI Number
    1121308
    Product Code
    MDD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 11, 2016
    Terminated
    September 13, 2016
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    Description

    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).

    Action

    Integra LifeSciences Inc. sent an urgent voluntary medical device recall letter/recall acknowledgement and return form dated March 11. 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product and immediately stop using and remove from service. Customers were asked to complete the attached form and return by email or fax as indicated on the form. Customers with questions were advised to contact Customer Service at 1-888-601-0203. For questions regarding this recall call 609-275-2700.

    Distribution

    Nationwide Distribution to PA

    Quantity

    14 packages