Events

Recall of Singlestage 3.5mm Healing Abutment, 4mm

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
    56785
  • Event Risk Class
    Class 2
  • Event Number
    Z-0321-2011
  • Event Initiated Date
    2010-09-07
  • Event Date Posted
    2010-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94499
  • 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
    Root-Form Endosseous Implant - Product Code DZE
  • Reason
    Healing abutment may not fully seat on the implant.
  • Action
    Consignees were notified by an Urgent: Medical Device Recall letter on 09/07/2010. The letter identified the affected product and gave some background regarding the issue. It also stated the possible impact and the cases that were not affected. Consignees were instructed to contact BioHorizons Returns & Complaints Manager Rick Self at 205-986-1250, if they have unused product from the affected lot, for a Return Authorization Number and to receive replacements. The attached Notification Certification form is to be completed and returned via fax.

Device

Singlestage 3.5mm Healing Abutment, 4mm
  • Model / Serial
    Lot #0903233
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.
  • Product Description
    Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. || Endosseous dental implant healing abutment.
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

BioHorizons Implant Systems Inc
  • Manufacturer Address
    BioHorizons Implant Systems Inc, 2300 Riverchase Ctr, Birmingham AL 35244-2808
  • Manufacturer Parent Company (2017)
    Henry Schein Inc
  • Source
    USFDA