Recall Z-2605-2025 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
ETHICON, LLC
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.
| Date | Sep 19, 2025 (initiated Aug 15, 2025) |
| Status | Open, Classified |
| Reason | Potential for barb non-engagement. |
| 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 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device ETHICON, Inc., Mar 25, 2020 |