Events

Recall of Device Recall PolyglycolicLactic Acid Absorbable Surgical Suture

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
    65584
  • Event Risk Class
    Class 2
  • Event Number
    Z-0347-2014
  • Event Initiated Date
    2012-12-13
  • Event Date Posted
    2013-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119650
  • 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, surgical, absorbable, polydioxanone - Product Code NEW
  • Reason
    Riverpoint medical is recalling pgla surgical suture (vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
  • Action
    Riverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement. For questions regarding this recall call 503-517-8001.

Device

Device Recall PolyglycolicLactic Acid Absorbable Surgical Suture
  • Model / Serial
    Lot 120716-01
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in the states of: AZ, FL, and TX.
  • Product Description
    Polyglycolic-Lactic Acid Absorbable Surgical Suture || Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" || PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues
  • 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