TEI Biosciences, Inc. recalls SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated,…

Recall date

May 23, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2070-2023

FDA classification

Class II

Brand / firm

TEI Biosciences, Inc.

Sold / distributed

Domestic: Nationwide Distribution.

Why it was recalled

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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