Integra LifeSciences Corporation: 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 number

Z-2777-2016

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 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

Status

Terminated

Initiated

2016-03-11

Posted

not on file

Terminated

2016-09-13

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).

Root cause

Under Investigation by 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.

Quantity

14 packages

Distribution

Nationwide Distribution to PA

Lot, serial or model codes

Catalogue No. MIDRT 8101 Lot No. 105A00324750

510(k) numbers

not on file

PMA numbers

not on file

Product code

MDD

Firm FEI

1121308

Firm city

Plainsboro

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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