TEI Biosciences, Inc. recalls PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and

Recalled July 12, 2023 · FDA recall Z-2078-2023 · 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

30,528 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 Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).

Manufacturer(s)

TEI Biosciences, Inc.

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