TEI Biosciences, Inc. recalls Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

Recalled July 12, 2023 · FDA recall Z-2084-2023 · 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

665 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-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

Manufacturer(s)

TEI Biosciences, Inc.

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