Events

Recall of Device Recall Zimmer Dental Torque Wrench

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pro-Dex Inc dba Dyna-Dent.

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
    53430
  • Event Risk Class
    Class 3
  • Event Number
    Z-1212-2010
  • Event Initiated Date
    2009-01-19
  • Event Date Posted
    2010-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85491
  • 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
    torque wrench - Product Code DZE
  • Reason
    Pro-dex has initiated a recall on their dental torque wrench. the recall was initiated due to an inaccurate laser etch identification of the torque value.
  • Action
    A "Voluntary Firm Initiated Recall" letter dated January 22, 2009, was sent to the customer. The letter describes the product, problem and action to be taken by the customer. The customer should immediately cease distribution or use of the noted lot; evaluate inventory and distribution records to ensure that this lot is removed from any potential point of use, and return the product to Returns Department at Pro-Dex, Inc . and include the RMA number on the shipping box. If you have any questions or concerns regarding this matter, please call (949) 769-3200.

Device

Device Recall Zimmer Dental Torque Wrench
  • Model / Serial
    PTW 421 (Lot IZCRQ)
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: CA
  • Product Description
    Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 || The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants.
  • Manufacturer
    Pro-Dex Inc dba Dyna-Dent

Manufacturer

Pro-Dex Inc dba Dyna-Dent
  • Manufacturer Address
    Pro-Dex Inc dba Dyna-Dent, 2361 McGaw Ave, Irvine CA 92614-5831
  • Manufacturer Parent Company (2017)
    Pro-Dex Inc
  • Source
    USFDA