FDAHealthAugust 15, 2025
ETHICON, LLC — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
⚠️ Potential for barb non-engagement.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 15, 2025
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.
What's affected?
- 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: SXPP2B400-11.
- Brand
- ETHICON, LLC
- Lot code
- 104DBB
Additional details
Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 516 units.
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