Recall Z-2082-2023— TEI Biosciences, Inc.

Name: FDA recall Z-2082-2023
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. It names one FDA 510(k) clearance: K100261. Product: PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).. 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

510(k) clearances named in this recall

1 on FDA's record

K100261 — PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDTei Biosciences, Inc.·cleared 2010-12-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).

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.