FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: 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
- Recall number
- Z-0116-2021
- Recalling firm
- Ethicon, Inc.
- 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
- Status
- Terminated
- Initiated
- 2020-09-09
- Posted
- not on file
- Terminated
- 2023-11-07
- Reason
- 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
- Root cause
- Packaging process control
- Action
- Ethicon issued Urgent Medical Device Recall Removal letter on 9/09/20 via email to responsible Johnson & Johnson Affiliates in affected countries who will be contacting all their impacted primary and secondary consignees and/or end customers. The letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall onhand and quarantine such product(s). 2.Remove the product subject to this recall and communicate the issue to relevant operating roomor materials management personnel, or anyone else in your facility who needs to be informed. 3.If any product subject to this recall has been forwarded to another facility, contact that facility toarrange return. Please consider including a copy of this recall letter when communicating. 4.Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice. Customers are required to return unused impacted VICRYL Suture, Product Code V960G, LotPJ5352 subject to this recall that are in their inventory immediately. To receive credit reimbursement, customers must return product subject to this recall no later than December 1,2020. Any non-affected product and any product returned after the date specified will not receive replacement.
- Quantity
- 1,032 eaches (OUS only)
- Distribution
- International distribution including the countries of Australia, Canada, Japan, and New Zealand
- Lot, serial or model codes
- Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28