STRATAFIX Spiral PDS Plus Violet 27 — Class II medical device recall Z-0048-2020
Terminated recall by Ethicon, Inc., reported 2019-10-16, distributed in AR, CA, CO, GA, IL, IN, KS, KY…. The product does not meet certain internal strength testing specifications.
| Recall number | Z-0048-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2019-08-13 |
| Classified | 2019-10-04 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2021-02-11 |
| Distributed | AR, CA, CO, GA, IL, IN, KS, KY, MD, NC, NJ, OH, OK, OR, PA, TN, UT, WA |
| Countries outside the US | AU, IN, JP, KR, SG, TH |
| Quantity | 852 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10705031236042 |
| Lot numbers | MMH401 |
Product
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Reason for recall
The product does not meet certain internal strength 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-0048-2020. 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.