TEI Biosciences, Inc.: SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestra

Hazard

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

Details from the source

Reason for recall: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Distribution: Domestic: Nationwide Distribution. Quantity: 5,664 units Lot/code info: Item No. (UDI-DI): 606-400-002 (10381780113201), 606-400-004 (10381780113218), 606-400-006 (10381780113225), 606-400-009 (10381780113232), 606-400-016 (10381780113249), 606-400-017 (10381780113256), 606-400-018 (10381780113263), 606-403-001 (10381780113270), and 606-404-001 (10381780113287).

UPC codes

10381780113201, 10381780113218, 10381780113225, 10381780113232, 10381780113249, 10381780113256, 10381780113263, 10381780113270, 10381780113287

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.