Ethicon recalls STRATAFIX SPIRAL sutures that may contain a PS-1 needle instead of the intended SH taper point needle, potentially causing more tissue trauma. Affected products have specific product numbers and expiry dates.
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
Ethicon is recalling STRATAFIX SPIRAL sutures that might have the wrong needle type, which could cause more tissue damage than expected. This recall affects specific product batches that were sold with certain serial numbers and expiry dates.
The recalled sutures may include a PS-1 cutting edge needle instead of the intended SH taper point needle. This difference in needle design could cause more tissue trauma during surgery than expected for taper point needles, potentially requiring additional repairs.
Surgical professionals and patients who used the recalled STRATAFIX SPIRAL sutures for soft tissue approximation. Those who received the specific product batch numbers listed in the recall are most at risk.
Check for product number SXMD1B405-12, UDI-DI 10705031228061, and lot/serial number B903HPU on the packaging. The product expires on 08/21/2026.
Look for product number SXMD1B405-12, UDI-DI 10705031228061, and lot/serial number B903HPU on the packaging.
The recalled sutures may contain a PS-1 cutting edge needle instead of the intended SH taper point needle, which could cause more tissue trauma than expected.
Check for product number SXMD1B405-12, UDI-DI 10705031228061, and lot/serial number B903HPU on the packaging. The product expires on 08/21/2026.
The recall does not require immediate discontinuation; however, you should check the product details to confirm if you have the recalled batch.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0150-2023 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0150-2023 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.
