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Updated 2025-10-01

ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Cont

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Recalled 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.

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Hazard / Issue

Potential for barb non-engagement.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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