TEI Biosciences, Inc.: 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-

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: 2,392 units 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).

UPC codes

10381780112976, 10381780112983, 10381780112990, 10381780113003, 10381780113010, 10381780113027, 10381780113034, 10381780113041, 10381780113058, 10381780113065

Source

Official record: FDA (Device enforcement) ↗

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