TissueMend recall: Endotoxin
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Why was TissueMend 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): 6495-9-001 (10381780113621), 6495-9-004 (10381780113638), 6495-9-006 (10381780113645).
- Product
- TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
- Recalling firm
- TEI Biosciences, Inc.
- Quantity
- 4,832
- Distribution
- Domestic: Nationwide Distribution.
- Recall date
- July 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)