Events

Recall of Polypropylene Surgical Sutures

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

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
    74891
  • Event Risk Class
    Class 2
  • Event Number
    Z-2762-2016
  • Event Initiated Date
    2016-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148695
  • 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, nonabsorbable, synthetic, polyamide - Product Code GAR
  • Reason
    Polypropylene surgical sutures are recalled because the seals may become open during distribution or subsequent packaging.
  • Action
    Riverpoint Medical sent an Urgent Medical Device letter, dated August 5. 2016, and the Customer Response Form to their customers via email. The letter identified the affected product, problem and actions to be taken. Customers are instructed to check inventory, discontinue selling affected sutures and return affected devices to the firm. Distributors are instructed to notify their downstream customers. Consignees should submit the Customer Response Forms. For questions call Riverpoint Medical at 1-866-445-4929.

Device

Polypropylene Surgical Sutures
  • Model / Serial
    Lot For Vet use: 160218-05V
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
  • Product Description
    Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 || Product Usage: || For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
  • Manufacturer
    Riverpoint Medical, LLC

Manufacturer

Riverpoint Medical, LLC
  • Manufacturer Address
    Riverpoint Medical, LLC, 825 NE 25th Ave, Portland OR 97232-2304
  • Manufacturer Parent Company (2017)
    Riverpoint Medical LLC
  • Source
    USFDA