Recall Z-2076-2023— TEI Biosciences, Inc.

Name: FDA recall Z-2076-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-23

Class II · Ongoing

Class II FDA medical device recall by TEI Biosciences, Inc., initiated 2023-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm. Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing..

Recalling firm: TEI Biosciences, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-23
Firm location: Boston, MA, United States

Product description

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

Reason for recall

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.