Medical device recalls Moderate risk

TEI Biosciences, Inc. recalls SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20…

Recall date
May 23, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2073-2023
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 MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.

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