Medical device recalls Moderate risk

TEI Biosciences, Inc. recalls PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

Recall date
May 23, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2081-2023
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

PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

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