Events

Recall of Device Recall ProLite Mesh

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

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
    79293
  • Event Risk Class
    Class 2
  • Event Number
    Z-0712-2018
  • Event Initiated Date
    2017-11-22
  • Event Date Posted
    2018-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161830
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Reason
    An incorrect prolite mesh configuration was packaged as product code 1010306-06, with lot number 412298. prolite mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
  • Action
    Please examine inventory to determine if you have any of the affected products listed on page 1. If so, please remove affected products, quarantine them, and place in a secure location. If you have affected product, please contact Getinge Customer Service at internationalcs@atriummed.com for a Return Authorization (RA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents, and using the shipping instructions provided, arrange for pick up with the designated delivery service provider. Please complete and sign the enclosed Urgent Medical Device Field Safety Notice to acknowledge receipt. Return the completed form to the following e-mail address: MESH2017@getinge.com For further questions, please call (973) 709-7654.

Device

Device Recall ProLite Mesh
  • Model / Serial
    Product Code/REF 1010306-06 Lot Number/LOT: 412298
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Internationally to Spain only.
  • Product Description
    ProLite Mesh - mesh, surgical, polymeric || ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Address
    Atrium Medical Corporation, 40 Continental Blvd, Merrimack NH 03054-4332
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA