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ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/
Recalled October 1, 2025 · FDA recall Z-2605-2025 · ETHICON
Hazard
Potential for barb non-engagement. · FDA Class II
Units
516 units
Sold at
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.
Description
Potential for barb non-engagement.
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.
Manufacturer(s)
ETHICON, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →