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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

FDA Recall Z-2777-2016 · Posted None

Recalling FirmIntegra LifeSciences Corporation
Recall StatusTerminated
Product CodeMDD
Date Initiated2016-03-11
Date Terminated2016-09-13
Product Quantity14 packages

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).

Firm 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.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution to PA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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