Device 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
Z-0480-2023
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 91192
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,560 eaches
- Official record key
device-enforcement:Z-0480-2023
Official wording
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
Code information: UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027
Distribution pattern: International (OUS) only: Canada, Japan, Australia and New Zealand
Derived failure modes
-
Unknown
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