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.
This recall is currently active, issued September 19, 2025. It was issued by Ethicon, Llc.
- Company
- Ethicon, Llc
- Recall Initiated
- August 15, 2025
- Posted
- September 19, 2025
- Recall Number
- Z-2605-2025
- Quantity
- 516 units
- Firm Location
- Guaynabo, PR
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
Root Cause
Under Investigation by firm
Action Taken
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 ethicon7924@sedgwick.com 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.