medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstructio

Recalled Product

SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.

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): 606-300-002 (10381780113072), 606-300-004 (10381780113089) 606-300-006 (10381780113096), 606-300-008 (10381780113102), 606-300-009 (10381780113119), 606-300-016 (10381780113126), 606-300-017 (10381780113133), 606-300-019 (10381780113140), 606-300-020 (10381780113157), 606-300-021 (10381780113164), 606-300-022 (10381780113171), 606-304-001 (10381780113188), and 606-304-002 (10381780113195).
View official government recall

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