Events

Recall of Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.

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
    35336
  • Event Risk Class
    Class 2
  • Event Number
    Z-1087-06
  • Event Initiated Date
    2006-05-04
  • Event Date Posted
    2006-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45886
  • 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, Absorbable, Synthetic, Polyglycolic Acid - Product Code GAM
  • Reason
    Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
  • Action
    The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.

Device

Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synt...
  • Model / Serial
    Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Japan, Canada, and Taiwan.
  • Product Description
    Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, (PO Box 151), Somerville NJ 08876
  • Source
    USFDA