Safety Alert: Class II: Potential for barb non-engagement.
healthClass IIRecalled on Oct 1, 2025
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4
🔢 516 units
Sold At: ETHICON, LLC(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.)
Recall #: FDA-DEVICE-Z-2605-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
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Summary
Potential for barb non-engagement.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact ETHICON, LLC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.