Z-2777-2016Class II

Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra Dermal...

Name: Z-2777-2016 Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra Dermal...
Creator: Integra LifeSciences Corporation
Published: 2016-03-11
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-03-11 / Terminated

FDA source

Integra LifeSciences Corporation began a recall of 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... on 2016-03-11. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2777-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Posted: 2016-09-09
Terminated: 2016-09-13
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
Product code: MDD Device, Dermal Replacement
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).
FDA 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 in commerce: 14 packages
Distribution: Nationwide Distribution to PA
Product codes and lots: Catalogue No. MIDRT 8101 Lot No. 105A00324750

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2777-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2777-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code MDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)