Recall Z-0480-2023— Ethicon, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ethicon, Inc., initiated 2022-11-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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.
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-16
- Firm location
- Somerville, NJ, United States
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.