medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 c

Recalled Product

PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.


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): 607-101-112 (10381780113492), 607-101-125 (10381780113508), 607-101-225 (10381780113515), 607-101-440 (10381780113522), 607-101-660 (10381780113539), 607-101-812 (10381780113546), 607-101-880 (10381780113553).
View official government recall

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