Recall Z-2072-2023— 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 2.0; 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, 20x25cm, 10x15cm Semi-Oval,. 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 2.0; 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, 20x25cm, 10x15cm Semi-Oval,
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.