Revize-X recall: Endotoxin
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Why was Revize-X 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): 611-005-001 (10381780357308), 611-005-002 (10381780357315).
- Product
- Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
- Recalling firm
- TEI Biosciences, Inc.
- Quantity
- 665 units
- Distribution
- Domestic: Nationwide Distribution.
- Recall date
- July 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)