Events

Recall of 8.5MM Bone Tap, Modular

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blackstone Medical, 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
    55508
  • Event Risk Class
    Class 2
  • Event Number
    Z-1615-2010
  • Event Initiated Date
    2010-04-21
  • Event Date Posted
    2010-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91013
  • 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
    Tap, bone - Product Code HWX
  • Reason
    Certain lots of the non-cannulated modular bone taps used with the firebird spinal fixation systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
  • Action
    Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm. For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.

Device

8.5MM Bone Tap, Modular
  • Model / Serial
    Part Number 52-1028; Lot numbers16380-xxxx and 17162-xxxx
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to one location each in Australia and Spain.
  • Product Description
    8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. || Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.
  • Manufacturer
    Blackstone Medical, Inc.

Manufacturer

Blackstone Medical, Inc.
  • Manufacturer Address
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Orthofix Medical, Inc.
  • Source
    USFDA