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

FDA Device Recall #Z-2777-2016 — Class II — March 11, 2016

Recall Summary

Recall Number Z-2777-2016
Classification Class II — Moderate risk
Date Initiated March 11, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Integra LifeSciences Corporation
Location Plainsboro, NJ
Product Type Devices
Quantity 14 packages

Product 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 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).

Distribution Pattern

Nationwide Distribution to PA

Lot / Code Information

Catalogue No. MIDRT 8101 Lot No. 105A00324750

Other Recalls from Integra LifeSciences Corporation

Recall # Classification Product Date
Z-1084-2015 Class II The MAYFIELD¿ Ultra 360 Base Unit for head posi... Dec 19, 2014
Z-1697-2014 Class II Integra Newdeal SURFIX Fixed Angle Locking Scre... Mar 28, 2014
Z-1736-2013 Class II Integra PANTA Arthrodesis Nail System. Inten... May 9, 2013
Z-1297-2013 Class II Ora Plug Absorbable Collagen Wound Dressing for... Mar 28, 2013
Z-1294-2013 Class II HeliTape Absorbable Collagen Wound Dressing for... Mar 28, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.