PDS II — Class II medical device recall Z-0480-2023
Ongoing recall by Ethicon, Inc., reported 2022-12-21. knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breaka
| Recall number | Z-0480-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2022-11-16 |
| Classified | 2022-12-14 |
| Reported by FDA | 2022-12-21 |
| Countries outside the US | AU, CA, JP, NZ |
| Quantity | 7,560 eaches |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10705031060623, 30705031060634 |
| Expiration dates | 2027-02-28 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0480-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.