Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

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

Code information: Item No. (UDI-DI): 611-005-001 (10381780357308), 611-005-002 (10381780357315).

Distribution pattern: Domestic: Nationwide Distribution.