medical Class II Updated 2023-07-12

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

Recalled Product

PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 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): 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), 607-005-220 (10381780357407).
View official government recall

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