Ethicon, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0116-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 9, 2020

Date Posted: October 28, 2020

Recall Number: Z-0116-2021

Event ID: 86437

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

Status: Terminated

Product Quantity: 1,032 eaches (OUS only)

Code Information:

Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324

Distribution Pattern:

International distribution including the countries of Australia, Canada, Japan, and New Zealand

Voluntary or Mandated:

Voluntary: Firm initiated