Device 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
Z-0116-2021
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 86437
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,032 eaches (OUS only)
- Official record key
device-enforcement:Z-0116-2021
Official wording
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
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
Derived failure modes
-
Unknown
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