FDA-Device2023-07-12Class II
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
TEI Biosciences, Inc.
Hazard
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Sold states
Domestic: Nationwide Distribution.
Affected count
7,264 units
Manufactured in
7 Elkins St, N/A, Boston, MA, United States
Products
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2081-2023Don't want to check this manually?
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