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TEI Biosciences, Inc. recalls SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 1
Recalled July 12, 2023 · FDA recall Z-2070-2023 · 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
22,163 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 PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
Manufacturer(s)
TEI Biosciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →