Events

Recall of Device Recall INFINITY Internal Hex Healing Abutment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ace Surgical Supply Co., 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
    76604
  • Event Risk Class
    Class 2
  • Event Number
    Z-1835-2017
  • Event Initiated Date
    2017-02-22
  • Event Date Posted
    2017-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153633
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    Incorrect device was packaged.
  • Action
    ACE sent a Customer Notice letter dated February 22, 2017 via certified mail to customers. The letter identified the affected product, problem, risk to health and actions to be taken. Customers were instructed to complete and return the enclosed Business Reply Form. For question call 1-800-441-3100 ext. 208.

Device

Device Recall INFINITY Internal Hex Healing Abutment
  • Model / Serial
    Lot Number: 16100050
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
  • Product Description
    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 || Product Usage: || Non implantable dental abutment.
  • Manufacturer
    Ace Surgical Supply Co., Inc.

Manufacturer

Ace Surgical Supply Co., Inc.
  • Manufacturer Address
    Ace Surgical Supply Co., Inc., 1034 Pearl St, Brockton MA 02301-5411
  • Manufacturer Parent Company (2017)
    Henry Schein Inc
  • Source
    USFDA