Events

Recall of VICRYL RAPIDE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0021-2009
  • Event Initiated Date
    2008-08-11
  • Event Date Posted
    2008-10-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73319
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Suture - Product Code GAM
  • Reason
    Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.
  • Action
    Letters were sent to distributors, Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Room on August 11, 2008, requesting that all affected lot numbers of Vicryl Rapide be discontinued immediately from sale and/or use. A separate correspondence was sent to hospitals. Letters to Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Rooms were advised of the recall and asked to discontinue use of any of the affected lot codes of sutures. Return and credit instructions were provided to the Director of Material Management. Contact Ethicon, Inc. at 1-908-218-2553 for assistance.

Device

VICRYL RAPIDE
  • Model / Serial
    Product code V2920G, Lot ZE8KPMR0, Exp 6/30/2012; Product code PN1695H, Lot ZG8BDZQ0, Exp. 6/30/2012; Product code V2920H, Lot ZG8BJQR0, Exp 6/30/2012; Product code V4731H, Lot ZG8BSSQ0, Exp 6/30/2012; Product code VR214, Lot ZG8BTSD0, Exp. 6/30/2012; Product code W9947, Lot ZG8BHPQ0, Exp 6/30/2012; Product code VR214, Lot ZG9CJXD0, Exp. 6/06/2012; Product code V4851H, Lot ZG8BZWQ0, Exp. 6/30/2012 and  Product code VR426, Lot ZG9BSPE0, Exp. 6/4/2012.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia.
  • Product Description
    VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. || Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876 || The product is used for Soft Tissue approximation.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA