Events

Recall of Device Recall Perioscopy Sheath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Danville Materials, 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
    74533
  • Event Risk Class
    Class 2
  • Event Number
    Z-2530-2016
  • Event Initiated Date
    2016-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147855
  • 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
    Unit, operative dental - Product Code EIA
  • Reason
    The perioscopy sheaths are currently provided with a label that indicates the sheath has a 3 year shelf-life/expiry date. danville materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
  • Action
    Recall letters were sent on June 24 to Distributor OEM and customers by traceable delivery method. Letters informed customers of the issue and the affect part and lot numbers. Pro duct is to be quarantined and returned. Distributors are instructed to contact all customers and provide a copy of the recall letter. The response form should be completed and returned by each consignee.

Device

Device Recall Perioscopy Sheath
  • Model / Serial
    Part number 1008: Lot numbers: 1133; 1135; 1136; 1137; 1138; 1163; 1171; 1172; 1173; 1174; 1175; 1218; 1240; 1243; 1258; 1264; 1264-1; 1275; 1276; 1277; 1311; 1314; 1315; 1325; 1326.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
  • Product Description
    Perioscopy Sheath: Part number: 1008; || The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
  • Manufacturer
    Danville Materials, Inc.

Manufacturer

Danville Materials, Inc.
  • Manufacturer Address
    Danville Materials, Inc., 3420 Fostoria Way Ste A200, San Ramon CA 94583-1327
  • Source
    USFDA