VICRYL recallZ-0116-2021 · Ethicon, Inc. · initiated Sep 9, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0116-2021
- Status
- Terminated
- Initiated by the company
- Sep 9, 2020
- Recalling firm
- Ethicon, Inc.
- Quantity
- 1,032 eaches (OUS only)
- Product code
- GAM
- Distribution
- International distribution including the countries of Australia, Canada, Japan, and New Zealand
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
Code information (models, lots, serial numbers)
Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VICRYL V960GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall55 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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