Recall Z-2069-2023— TEI Biosciences, Inc.

Name: FDA recall Z-2069-2023
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: K071807. Product: SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.. 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

K071807 — ORTHOMEND SOFT TISSUE MATRIXTei Biosciences, Inc.·cleared 2007-08-06

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

SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.

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.