medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstructio

Recalled Product

SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.


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): 606-005-003 (10381780112952) and 606-005-004 (10381780112969).
View official government recall

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