FDA recall Z-2605-2025

ETHICON, LLC · Class II · 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.

Reason for recall

Potential for barb non-engagement.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-08-15
Report date
2025-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Guaynabo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2605-2025