ETHICON, LLC: Device Recall

Recall Details

Recall Number

Z-2605-2025

Classification

Class II

Product Type

Device

Recalling Firm

ETHICON, LLC

Status

Ongoing

Date Initiated

08/15/2025

Location

Guaynabo, PR, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

516 units

Reason for Recall

Potential for barb non-engagement.

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.

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.

Other Recalls by ETHICON, LLC

• Class II: Risk 12/20/2024
  Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
• Class II: Risk 12/20/2024
  Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
• Class II: Risk 12/20/2024
  Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

View all recalls by ETHICON, LLC →