medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes

Recalled Product

PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).


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): 607-105-112 (10381780177685), 607-105-125 (10381780113591), 607-105-225 (10381780113607), 607-105-440 (10381780113614), 607-105-660 (10381780177715), 607-105-812 (10381780177739), 607-105-880 (10381780177722).
View official government recall

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