Z-2605-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2025
- Initiation Date
- August 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 516 units
Product Description
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.
Reason for Recall
Potential for barb non-engagement.
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.
Code Information
Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.