TEI Biosciences, Inc. recalls SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x4…
- Recall date
- May 23, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2075-2023
- 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 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
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