Z-2605-2025 Class II Ongoing
FDA device recall Z-2605-2025 was initiated by ETHICON, LLC on Aug 15, 2025 and is designated Class II. Reason for recall: Potential for barb non-engagement. The recall status is ongoing. Affected quantity: 516 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 1, 2025
- Initiation Date
- Aug 15, 2025
- 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2605-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026