Events

Recall of Device Recall KLSBP001 Battery Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pro-Dex 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
    73034
  • Event Risk Class
    Class 2
  • Event Number
    Z-1095-2016
  • Event Initiated Date
    2015-12-23
  • Event Date Posted
    2016-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142867
  • 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
    Battery, replacement, rechargeable - Product Code MOQ
  • Reason
    The sterile battery may contain particulates within the sterile package.
  • Action
    A customer notification letter was sent 12/23/15. The letter instructs the customer to cease distribution and use of the recalled lots. It also recommends that the inventory and distribution records be evaluated immediately to ensure that affected product is removed from any potential point of use. Return product to: Returns Department (Recall complaint ClS-001) Pro-Dex, Inc 2361 McGaw Avenue Irvine, California 92614 USA Reference the Recall Complaint # on the outside of the shipping box. If any questions or concerns, please contact the QARA group at Pro-Dex at 949 769 3200.

Device

Device Recall KLSBP001 Battery Pack
  • Model / Serial
    Lots 509567, K055R
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in FL.
  • Product Description
    Battery Pack || KLS-SD-1000 || Single || Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
  • Manufacturer
    Pro-Dex Inc

Manufacturer

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