VICRYL MONOFILAMENT VIOLET 4IN — Class II medical device recall Z-0116-2021
Terminated recall by Ethicon, Inc., reported 2020-10-28. Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VI
| Recall number | Z-0116-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2020-09-09 |
| Classified | 2020-10-16 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2023-11-07 |
| Countries outside the US | AU, CA, JP, NZ |
| Quantity | 1,032 eaches |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10705031051324 |
| Serial numbers | PJ5352 |
| Expiration dates | 2024-07-31 |
Product
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
Reason for recall
Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
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-0116-2021. 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.