Integra LifeSciences Corporation: Medical Device Recall in 2016 - (Recall #: Z-2777-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 11, 2016

Date Posted: September 21, 2016

Recall Number: Z-2777-2016

Event ID: 73689

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).

Status: Terminated

Product Quantity: 14 packages

Code Information:

Catalogue No. MIDRT 8101 Lot No. 105A00324750

Distribution Pattern:

Nationwide Distribution to PA

Voluntary or Mandated:

Voluntary: Firm initiated