Reported Oct 1, 2025 · Ongoing
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4)…
Ethicon, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ETHICON, LLC · 475 Calle C Ste 401 · Guaynabo, PR · 00969-4292
Is this the product you have?
- STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4
- Product CodeSXPP2B400-11
- Lot codes and dates
- Product CodeSXPP2B400-11
- GTIN
10705031464568 (each)30705031464562 (box of 12)
- Lot Number104DBB
- Amount recalled
- 516 units
Where it was sold
Why it was recalled
Potential for barb non-engagement.
This product could cause temporary or reversible health problems — stop using it.
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