STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/
FDA device recall Z-2605-2025 · posted 2025-09-19 · Open, Classified
Recall details
- Recalling firm
- ETHICON, LLC
- Reason for recall
- Potential for barb non-engagement.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NEW
- Quantity affected
- 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.
- Date initiated
- 2025-08-15
- Date posted
- 2025-09-19
- Location
- Guaynabo, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (K192144) | ETHICON, Inc. | 2020-03-25 |