Events

Recall of Device Recall Rely X

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Espe Dental Products.

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
    37635
  • Event Risk Class
    Class 2
  • Event Number
    Z-0800-2007
  • Event Initiated Date
    2007-02-12
  • Event Date Posted
    2007-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51189
  • 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
    Dental Cement - Product Code EBF
  • Reason
    Cement in 3m espe relyx veneer cement refill a3 shade syringes, may not cure to the degree expected.
  • Action
    All consignees including distributors were notified of the recall via telephone or mail on 2/27/2007. Communication with distributors included the product being recalled, the problem , recommended stop usage or distribution and directions for return shippment. Further, the consignees were also sent a letter which described the product and problem and what to do if the product was still availabe or had been used.

Device

Device Recall Rely X
  • Model / Serial
    7CG code on syringe (Lot 20070124 on box/bag)
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.
  • Product Description
    3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.
  • Manufacturer
    3M Espe Dental Products

Manufacturer

3M Espe Dental Products
  • Manufacturer Address
    3M Espe Dental Products, 2111 Mcgaw Ave, Irvine CA 92614-0908
  • Source
    USFDA