TEI Biosciences, Inc. recalls PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 c

Recalled July 12, 2023 · FDA recall Z-2079-2023 · TEI Biosciences

Hazard

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. · FDA Class II

Units

33,277 units

Sold at

Domestic: Nationwide Distribution.

Description

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Product

PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).

Manufacturer(s)

TEI Biosciences, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →