medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx O

Recalled Product

Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.


Hazard / Issue

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Item No. (UDI-DI): 611-001-001 (10381780357292), 611-001-002 (10381780357278), 611-001-003 (10381780357285).
View official government recall

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