Events

Recall of Device Recall Pelton & Crane

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pelton & Crane Company.

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
    61262
  • Event Risk Class
    Class 2
  • Event Number
    Z-1177-2012
  • Event Initiated Date
    2012-02-20
  • Event Date Posted
    2012-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107682
  • 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
    Modification of the pelton & crane spirit 3000 unit disabled the tlc safedrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.
  • Action
    Pelton & Crane sent an Urgent Medical Device Recall letter dated February 20, 2012 to all affected customers. The letter identifies the affected product, problem and actions to be taken. The letter states that a Pelton & Crane representative will be contacting the customers to schedule a service appointment with the end user of the device so that the affected TLC SAFEdrive circuit board can be replaced and returned to Pelton & Crane. Customers were instructed to complete the attached Recall Acknowledgement/Return Form and fax it to Pelton & Crane, attention Frank Ray, at (704) 587-7250. The letter also requested customers to mail the original Recall Acknowledgement/Return Form in the enclosed self addressed stamped envelope.

Device

Device Recall Pelton & Crane
  • Model / Serial
    Model #SET30, Catalog #3120, Serial numbers 4096 and 4099.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide Distribution
  • Product Description
    Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 || Product Usage: || The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up.
  • Manufacturer
    Pelton & Crane Company

Manufacturer

Pelton & Crane Company
  • Manufacturer Address
    Pelton & Crane Company, 11727 Fruehauf Dr, Charlotte NC 28273
  • Manufacturer Parent Company (2017)
    Pelton & Crane Company
  • Source
    USFDA