medical Class II Updated 2023-07-12

TEI Biosciences, Inc. recalls SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Recons

Recalled Product

SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm


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. 606-907-001. No UDI-DI (Distributed in Canada and EU).
View official government recall

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