Home / Recalls / Medical Devices
TEI Biosciences, Inc. recalls TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Recalled July 12, 2023 · FDA recall Z-2085-2023 · 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
4,832
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
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Manufacturer(s)
TEI Biosciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →