Ethicon recalls violet monofilament PDS II sutures with low knot strength that could break during surgery. Affected units have product code Z340H and expire February 2027. Stop using immediately.
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
Ethicon is recalling violet monofilament PDS II sutures that may break during surgery due to weak knots. This could cause surgical complications if the suture fails while stitching tissue.
The suture knots have weaker strength than required, meaning they could snap during surgery or before the procedure ends. This might cause tissue damage or require emergency repairs if the suture breaks while stitching.
Surgical teams using the recalled suture for soft tissue procedures, especially pediatric cardiovascular surgeries and eye operations. Patients undergoing these procedures with the affected suture are at risk.
Check for the product code Z340H on the suture packaging. The suture is violet in color, 27 inches long, and labeled for soft tissue use. It expires February 2027.
Discard the suture if you have it, as it may break during surgery.
The recall includes suture for ophthalmic surgery, so yes, affected units are included.
Look for product code Z340H on the packaging, violet color, 27-inch length, and expiration date February 2027.
If you're a surgical team using the suture, stop using it immediately and contact your surgeon.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0480-2023 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0480-2023 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.
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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.
