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).
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