Events

Recall of Device Recall Rotating Cutter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthofix, 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
    61117
  • Event Risk Class
    Class 2
  • Event Number
    Z-1037-2012
  • Event Initiated Date
    2012-02-06
  • Event Date Posted
    2012-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107325
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    surgical instrument - Product Code max
  • Reason
    The 8mm and 10mm rotating cutters may fracture during use, specifically during disc space preparation. if an 8mm or 10mm rotating cutter does fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
  • Action
    Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.

Device

Device Recall Rotating Cutter
  • Model / Serial
    Catalog Number 89-0452 (8mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND25 and 33056-NE19; Catalog Number 89-0454 (10mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND26 and 33056-NF02; Catalog Number 89-0030 (FORZA Discectomy Case);   UPDATED INFORMATION AS OF 04/12/2012: The firm has revised to amend the affected lot information; lot number 34346-NH30 (PN 89-0545) has been added. At the time of recall initiation 3 units from lot 34346-NH30 were in distribution; all 3 units have since been returned to Orthofix. Recall notice stated all lots are to be returned so all other information remains unchanged.
  • Product Classification
    Orthopedic Devices
  • Distribution
    Nationwide and Puerto Rico
  • Product Description
    Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.
  • Manufacturer
    Orthofix, Inc.

Manufacturer

Orthofix, Inc.
  • Manufacturer Address
    Orthofix, Inc., 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Manufacturer Parent Company (2017)
    Orthofix International Nv
  • Source
    USFDA