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.
FDA Recall Z-2605-2025 · Posted 2025-09-19
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Recalling FirmETHICON, LLC
Recall StatusOpen, Classified
Product CodeNEW
Date Initiated2025-08-15
Product Quantity516 units
Reason for Recall
Potential for barb non-engagement.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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