Recall Z-2074-2023— TEI Biosciences, Inc.
Class II · Ongoing
Class II FDA medical device recall by TEI Biosciences, Inc., initiated 2023-05-23. It names one FDA 510(k) clearance: K083898. Product: SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.. 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 recordK-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 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
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.