STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue recall
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code…
Why was STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue recalled?
Potential for barb non-engagement.
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?
Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
- Product
- STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code…
- Recalling firm
- ETHICON, LLC
- Quantity
- 516 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia.
- Recall date
- October 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)