1 STRATAFIX" Spiral PDS Plus Violet 36" — Class II medical device recall Z-1335-2020
Terminated recall by Ethicon, Inc., reported 2020-02-26. The product do not meet certain internal testing specifications.
| Recall number | Z-1335-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2019-08-28 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-02-11 |
| Countries outside the US | AU, IN, JP, KR, SG, TH |
| Quantity | 660 units |
| UPC / GTIN / UDI-DI | 10705031236059 |
| Lot numbers | PAH054, PAH073 |
| Expiration dates | 2020-12-31 |
Product
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Reason for recall
The product do not meet certain internal testing specifications.
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-1335-2020. 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.