SurgiMend 4.0 recall: Endotoxin
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm…
Why was SurgiMend 4.0 recalled?
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item No. (UDI-DI): 606-400-002 (10381780113201), 606-400-004 (10381780113218), 606-400-006 (10381780113225), 606-400-009 (10381780113232), 606-400-016 (10381780113249), 606-400-017 (10381780113256), 606-400-018 (10381780113263), 606-403-001 (10381780113270), and 606-404-001 (10381780113287).
- Product
- SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm…
- Recalling firm
- TEI Biosciences, Inc.
- Quantity
- 5,664 units
- Distribution
- Domestic: Nationwide Distribution.
- Recall date
- July 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)