Events

Recall of Device Recall Disposable Drill Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ad-Tech Medical Instrument Corporation.

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
    80002
  • Event Risk Class
    Class 2
  • Event Number
    Z-1938-2018
  • Event Initiated Date
    2017-12-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164195
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    There is a possibility that ddk2-2.4-30x disposable drill kits, lot number 111664 208140649 contained 2.8mm drill bits from ddk2-2.8-30x disposable drill kits, lot number 111745 208140649 and vice versa.
  • Action
    The firm, Ad-Tech Medical Instrument Corporation, sent a "MEDICAL DEVICE RECALL" letter on approximately 12/20/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine inventory and quarantine any affected product on hand; notify customers of the recall if affected product was further distributed; complete and return the Acknowledgement and Receipt Form via Fax to: 262-634-5668, Attention Customer Support; Mail to: AD-TECH MEDICAL INSTRUMENT CORPORATION, 1901 WILLIAM STREET, RACINE, WI 53404 or Email to: customersupport@adtechmedical.com, and contact an Ad-Tech Customer Support Specialist for a Return Material Authorization (RMA) number. If you have any further questions, contact Regulatory Team Representative and CAPA/Complaints Manager, Monday through Friday, 7:00 AM to 5:00 PM, Central Time via FAX: 262-634-5668, Toll Free: 1-800-776-1555 or Email: customersupport@adtechmedical.com.

Device

Device Recall Disposable Drill Kit
  • Model / Serial
    Catalog No. DDK2-2.4-30X, Lot No. 0111664 208140649, UDI No. 01008418231011741719080110011174 5208140649;   Catalog No. DDK2-2.8-30X, Lot No. 0111745 208140649, UDI No. 01008418231011671719080110011166 4208140649
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: CA, DC, FL, MI, MA, NC, NY, WA, WI; and country of: Canada. Distributed internationally to the United Kingdom.
  • Product Description
    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. || Used to drill cranial holes using a stereotactic frame.
  • Manufacturer
    Ad-Tech Medical Instrument Corporation

Manufacturer

Ad-Tech Medical Instrument Corporation