TEI Biosciences, Inc. recalls SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40

Recalled July 12, 2023 · FDA recall Z-2075-2023 · 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

5,664 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

SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.

Manufacturer(s)

TEI Biosciences, Inc.

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