FDA-Device2023-07-12Class II
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
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
2,392 units
Manufactured in
7 Elkins St, N/A, Boston, MA, United States
Products
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2023Don't want to check this manually?
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