Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Recalled by Ethicon, Inc. Due to knot tensile strengths were observed to be significantly...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon, Inc. directly.
Affected Products
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
Quantity: 7,560 eaches
Why Was This Recalled?
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
Where Was This Sold?
International (OUS) only: Canada, Japan, Australia and New Zealand
About Ethicon, Inc.
Ethicon, Inc. has 69 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report