Events

Recall of Device Recall Biohorizons Maximus surgical kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioHorizons Implant Systems 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
    36764
  • Event Risk Class
    Class 3
  • Event Number
    Z-0252-2007
  • Event Initiated Date
    2005-12-28
  • Event Date Posted
    2006-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49328
  • 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
    dental implant - Product Code DZE
  • Reason
    Dental implants were distributed which lacked the proper instruments for implantation.
  • Action
    The firm initiated a recall on December 28, 2005 via US Mail. The letter explains the new implants introduced and explains the need for two additional instruments, the Handpiece and Ratchet Adapter, which are necessary to implant the new one-piece, ball-top 3.0mm diameter implant. A second letter was sent to all non-responding consignees on October 20, 2006 stating the same. The distributors were notified by electronic mail on 11/01/2006.

Device

Device Recall Biohorizons Maximus surgical kit
  • Model / Serial
    Lot Nos.: K1103005, K1203002, K1203006, K0104001, K0104004, K0104005, K0204001, K0204007, K0204008, K0304001, K0304007, K0404001, K0404008, K0504003, K0604003, K0704002,
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Australia, Brazil, Canada, Chile, Colombia, Egypt, El Salvador, India, Israel, Italy, Ireland, Germany, Japan, Kuwait, Latvia, Lithuania, Mexico, Romania, Russia, Singapore, South Africa, Taiwan, United Arab Emirates, and United Kingdom.
  • Product Description
    BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

BioHorizons Implant Systems Inc
  • Manufacturer Address
    BioHorizons Implant Systems Inc, One Perimeter Park South, Suite 230, South, Birmingham AL 35243
  • Source
    USFDA