Ethicon recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device due to potential barb non-engagement. Affected units sold from MO-4 date. Contact Ethicon for details.
Potential for barb non-engagement.
Ethicon is recalling a type of surgical device called STRATAFIX Spiral PDS Plus that may not engage properly with tissue. This could lead to the device failing during surgery, potentially causing complications for patients.
The device's barbs may not securely attach to tissue during surgery. If the barbs fail to engage, the device could slip out of place, potentially causing tissue damage or requiring additional surgical intervention.
Surgical professionals and patients who use this device during procedures. Those with the specific product code or lot number are most at risk.
Check for product code SXPP2B400-11 or lot number 104DBB. The device was sold with a date of manufacture (D/A) of MO-4.
Look for product code SXPP2B400-11 or lot number 104DBB on the device packaging.
The recall states there is a potential for barb non-engagement, which could lead to the device failing during surgery. However, the exact risk level is not specified in the notice.
Check for product code SXPP2B400-11 or lot number 104DBB on the device packaging. The device was sold with a date of manufacture (D/A) of MO-4.
The recall does not specify a remedy, so contact Ethicon directly for guidance on next steps.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2605-2025 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2605-2025 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
