medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstructio

Recalled Product

SurgiMend 2.0; 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, 20x25cm, 10x15cm Semi-Oval,

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): 606-200-002 (10381780112976), 606-200-004 (10381780112983), 606-200-006 (10381780112990), 606-200-008 (10381780113003), 606-200-009 (10381780113010), 606-200-016 (10381780113027), 606-200-017 (10381780113034), 606-200-019 (10381780113041), 606-200-020 (10381780113058), and 606-204-100 (10381780113065).

View official government recall

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