Events

Recall of Device Recall Peak SE Primer Refill

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ultradent Products, 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
    62120
  • Event Risk Class
    Class 2
  • Event Number
    Z-1822-2012
  • Event Initiated Date
    2012-05-24
  • Event Date Posted
    2012-06-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109878
  • 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
    Agent, tooth bonding, resin - Product Code KLE
  • Reason
    Ultradent is recalling lot b6z4k of peak se primer as a result of a field complaint, dated may 10, 2012, stating that a syringe of peak se primer was mislabeled as peak lc bond resin. these products are used by dental professionals for bonding needs in restorative dental procedures.
  • Action
    Ultradent Products Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discard any affected product from their 5135 kit. Customers were asked to complete and return a Recall Return Response form to the firm by fax at 801-553-4609.

Device

Device Recall Peak SE Primer Refill
  • Model / Serial
    Lot number: B6Z4K.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. || The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • Manufacturer Address
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3935
  • Manufacturer Parent Company (2017)
    Ultradent Products Inc
  • Source
    USFDA