FDA-Device2025-10-01Class II
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.
Hazard
Potential for barb non-engagement.
Sold states
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.
Affected count
516 units
Manufactured in
475 Calle C Ste 401, N/A, Guaynabo, PR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2605-2025Want us to check the next one for you?
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