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Class 2 Device Recall VICRYL MONOFILAMENT VIOLET |
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Date Initiated by Firm |
September 09, 2020 |
Create Date |
October 16, 2020 |
Recall Status1 |
Terminated 3 on November 07, 2023 |
Recall Number |
Z-0116-2021 |
Recall Event ID |
86437 |
Product Classification |
Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
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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 |
Code Information |
Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324 |
Recalling Firm/ Manufacturer |
Ethicon, Inc. Us Highway 22 West Somerville NJ 08876
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For Additional Information Contact |
SAME 908-218-0707
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Manufacturer 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
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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