Z-2605-2025Class II

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM)...

Name: Z-2605-2025 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM)...
Creator: Ethicon, Llc
Published: 2025-08-15
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2025-08-15 / Open, Classified

FDA source

ETHICON, LLC began a recall of 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 on 2025-08-15. FDA classified it as Class II and gives the reason as "Potential for barb non-engagement". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2605-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-15
Posted: 2025-09-19
Recalling firm: Ethicon, Inc
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.
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Potential for barb non-engagement.
FDA root cause: Under Investigation by firm
Action: On August 15, 2025, Ethicon, LLC issued an " Urgent Medical Device Recall (Removal)" Notification. Ethicon asked consignees to take the following actions: 1. Examine stock and quarantine affected product. 2. Share notification with all personnel. 3. Complete the response form and and fax 888-202-5865 or email [email protected] 4. Return all unused product. 5. Keep this notice visibly posed for awareness. 6. If assistance is needed, please contact Sedgwick at 888-266-7913 and reference Event # 7924.
Quantity in commerce: 516 units
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.
Product codes and lots: Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2605-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2605-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19

Product code NEW

K192144Class IISTRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. / cleared 2020-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)