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
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
Potential for barb non-engagement.