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Recall Observatory FDA recall evidence

Device 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.

Z-2605-2025

August 15, 2025

Class II

Product summary

Firm
ETHICON, LLC
Event
Event 97471
Status
Ongoing
Classification
Class II
Quantity
516 units
Official record key
device-enforcement:Z-2605-2025

Official wording

Reason: Potential for barb non-engagement.

Code information: Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for barb non-engagement.