STRATAFIX Surgical Device (Ethicon) – Barb Non-Engagement (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
ETHICON, LLC
Lot Codes / Batch Numbers
Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
Products Sold
Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
ETHICON, LLC is recalling STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN( due to Potential for barb non-engagement.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for barb non-engagement.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026