FDA-Device2023-07-12Class II
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
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
52 units
Manufactured in
7 Elkins St, N/A, Boston, MA, United States
Products
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2071-2023Don't want to check this manually?
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