Z-0116-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- September 9, 2020
- Termination Date
- November 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,032 eaches (OUS only)
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
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
Distribution Pattern
International distribution including the countries of Australia, Canada, Japan, and New Zealand
Code Information
Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324