Recall Z-2605-2025— ETHICON, LLC

Name: FDA recall Z-2605-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-15

Class II · Ongoing

Class II FDA medical device recall by ETHICON, LLC, initiated 2025-08-15. It names one FDA 510(k) clearance: K192144. 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: Potential for barb non-engagement..

Recalling firm: ETHICON, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-08-15
Firm location: Guaynabo, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.·cleared 2020-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.