Z-0116-2021Class II

Vicryl Monofilament Violet 4In (10Cm) Usp 10-0 (M0.2) Single-Armed Cs140-6 -

Name: Z-0116-2021 Vicryl Monofilament Violet 4In (10Cm) Usp 10-0 (M0.2) Single-Armed Cs140-6 -
Creator: Ethicon, Inc.
Published: 2020-09-09
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2020-09-09 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product... on 2020-09-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0116-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-09
Posted: 2020-10-16
Terminated: 2023-11-07
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
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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
Root cause tag: packaging
FDA 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 in commerce: 1,032 eaches (OUS only)
Distribution: International distribution including the countries of Australia, Canada, Japan, and New Zealand
Product codes and lots: Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0116-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0116-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-16

Product code GAM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)