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TEI Biosciences, Inc. recalls SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Recalled July 12, 2023 · FDA recall Z-2071-2023 · 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
52 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 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Manufacturer(s)
TEI Biosciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →