ETHICON recalled 516 units of the STRATAFIX Spiral PDS Plus device on August 15, 2025. The recall follows reports of potential barb non-engagement that could affect surgical procedures. Healthcare providers and patients must stop using the device immediately.
Potential for barb non-engagement.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ETHICON, LLC or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, Product Code SXPP2B400-11. It was distributed in the U.S. states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI, and in Singapore and Malaysia.
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