medical Class II Updated 2023-07-12

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

Recalled Product

Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 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): 611-005-001 (10381780357308), 611-005-002 (10381780357315).
View official government recall

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