TEI Biosciences, Inc. recalls PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and…
- Recall date
- May 23, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2078-2023
- 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 Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
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