medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; S

Recalled Product

PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 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): 607-104-125(10381780113775) , 607-104-225 (10381780113782), 607-104-440 (10381780113560), 607-104-660 (10381780113577), 607-104-812 (10381780113768), 607-104-880 (10381780113584).
View official government recall

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