Events

Recall of Device Recall Bard Mesh Monofilament Knitted Polypropylene

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ram Medical 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
    54884
  • Event Risk Class
    Class 1
  • Event Number
    Z-1648-2010
  • Event Initiated Date
    2010-03-05
  • Event Date Posted
    2010-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89631
  • 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
    Counterfeit product mixed with authentic product. the problem was recognized by the mismatching of expiration dates and the subtle differences in packaging.
  • Action
    Ram Medical Inc., contacted Customers by phone beginning March 4, 2010 and issued "Urgent Device Recall" notifications beginning March 8, 2010. Further notifications were issued to expand the scope of the recall by the firm. Each notification described the affected product and asked the User to complete a Recall Acknowledgement Form and return it to the firm. All affected product should be returned to the firm. For further information, contact Ram Medical, Inc. at 1-973-633-0400 Monday through Friday, 9:00 AM to 5:00 PM EST.

Device

Device Recall Bard Mesh Monofilament Knitted Polypropylene
  • Model / Serial
    Item Code: 0112660, Lot Numbers: HUSD0629 and HURL0336.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- CO, IL , NY, MO and FL.
  • Product Description
    Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. || Intended as reinforcement of soft tissue where weakness exists.
  • Manufacturer
    Ram Medical Inc

Manufacturer

Ram Medical Inc
  • Manufacturer Address
    Ram Medical Inc, 4 Haul Rd, Wayne NJ 07470-6625
  • Manufacturer Parent Company (2017)
    Ram Medical Inc
  • Source
    USFDA