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U.S. Department of Health and Human Services

Class 2 Device Recall STRATAFIX Spiral

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 Class 2 Device Recall STRATAFIX Spiralsee related information
Date Initiated by FirmAugust 15, 2025
Date PostedSeptember 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2605-2025
Recall Event ID 97471
510(K)NumberK192144 
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
ProductSTRATAFIX 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.
Code Information Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
Recalling Firm/
Manufacturer		 ETHICON, LLC
475 Calle C Ste 401
Guaynabo PR 00969-4292
For Additional Information Contact
1877-384-4266
Manufacturer Reason
for Recall		Potential for barb non-engagement.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce516 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NEW
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