Events

Recall of Bioplate Resorbable Bone

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bioplate 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
    36362
  • Event Risk Class
    Class 2
  • Event Number
    Z-0043-2007
  • Event Initiated Date
    2006-09-12
  • Event Date Posted
    2006-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48484
  • 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
    Bone Fixation - Product Code JEY
  • Reason
    Lack of device sterilization: an internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
  • Action
    Customers were notified via telephone initially on 09/14/2006 to return product, and this was followed up within two days with a certified mail/return receipt required, recall notification letter. 100% of the consignees will be notified of the recall. Bioplate will fax and call non-responsive customers afler 5 days via telephone call. Customers not responding to the first recall notification will be sent a second notification certified mail recall notification.

Device

Bioplate Resorbable Bone
  • Model / Serial
    Lot number: S29640905
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide to: CA, DC, GA, MI, OH, & PA
  • Product Description
    Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
  • Manufacturer
    Bioplate Inc

Manufacturer

Bioplate Inc
  • Manufacturer Address
    Bioplate Inc, 3643 Lenawee Ave, Los Angeles CA 90016-4310
  • Manufacturer Parent Company (2017)
    Bioplate Inc
  • Source
    USFDA