Events

Recall of Device Recall G1 High Speed Electric Handpiece Air Cooled (eG1A)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Anspach Effort, 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
    74447
  • Event Risk Class
    Class 2
  • Event Number
    Z-2253-2016
  • Event Initiated Date
    2016-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147607
  • 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
    Motor, drill, electric - Product Code HBC
  • Reason
    The graphics at the attachment interface indicating locked and unlocked position are reversed.
  • Action
    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE-RECALL (Removal)" letter dated June 15, 2016 to its customers. The letter described the product, problem and actions to taken. The customers were instructed to review your inventory and immediately remove the product subject to this recall from stock; If you DO HAVE any of the identified devices, please take the following steps: " Ensure anyone in your facility impacted by this notification reads this letter carefully. Customer Letter Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating product subject to the recall has been located. Indicate the number of devices found. " The RMA information has been filled in for your convenience. " Please include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by: " Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFieldActions@its.jnj.com " Giving it to your DePuy Synthes Sales Consultant. " This return documentation acknowledges your receipt of medical device removal information. " Return the affected product to your DePuy Synthes Sales Consultant " Keep this notice visibly posted for awareness until all products subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. If you DO NOT HAVE the identified product, please take the following steps: " Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFiel

Device

Device Recall G1 High Speed Electric Handpiece Air Cooled (eG1A)
  • Model / Serial
    Lot #'s: H29309439804, H44310033104, K09311396703, and K09311396704.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US Distribution to states of: GA and FL; and country of: Switzerland.
  • Product Description
    Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) || Use for cutting and shaping bone including bones of the cranium and spine.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Dr, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA