FDA Medical devices recall ·
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device… recall
- Recall number
- Z-2605-2025
- Date
- (initiated August 15, 2025)
- Company / brand
- Ethicon, LLC
475 Calle C Ste 401, Guaynabo, PR, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 516 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for barb non-engagement.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.
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.
States: Arkansas Arizona California Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri North Carolina New Hampshire New Mexico Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2605-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.