TEI Biosciences, Inc. recalls Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.

Recalled July 12, 2023 · FDA recall Z-2083-2023 · 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

199 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

Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.

Manufacturer(s)

TEI Biosciences, Inc.

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