Events

Recall of Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybron Dental Specialties.

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
    70551
  • Event Risk Class
    Class 2
  • Event Number
    Z-1291-2015
  • Event Initiated Date
    2015-02-11
  • Event Date Posted
    2015-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134019
  • 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
    Cover, barrier, protective - Product Code MMP
  • Reason
    Cases of cure sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. there is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
  • Action
    The firm sent out letters to customers on 02/11/15. The firm's letter states that they are willing to replace or credit back customers if they have any of the affected product, and instruct them to contact Metrex Research Customer Care at 1-800-841-1428 in order to receive an RMA number. The firm also requests that customer complete and fax back the enclosed reply form in order to confirm receipt of this advisory notification. The firm also states that if the customer is a distributor that they identify the customers that might have received the affected product, and contact them within 48 hours.

Device

Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve
  • Model / Serial
    Part Number: 4513C or 4513-1.  Lot Number: 2014030110
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
  • Product Description
    Outer cardboard box labeling: || Pinnacle Cure Sleeve, Curing Light Tip Sleeves. || Kerr Total Care. || Part Number: 4513C or 4513-1 || Single Patient Use || Fits 13mm Tips. Pack of 400. || Metrex Research, Manufacturer. || Inner individual packaging of each sleeve: || Cure Sleeve by Pinnacle || Model 4500
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • Manufacturer Address
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA