Events

Recall of Device Recall XCaliber Ankle Complete Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthofix Srl.

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
    55182
  • Event Risk Class
    Class 2
  • Event Number
    Z-1435-2010
  • Event Initiated Date
    2010-02-22
  • Event Date Posted
    2010-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90241
  • 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
    Pin, fixation, threaded - Product Code JDW
  • Reason
    During standard quality controls, firm identified a potential for breakage of the xcaliber clamp when locking the cam.
  • Action
    Orthofix issued an "Urgent: Field Safety Notice" dated February 22, 2010. Consignees were informed of the affected product and instructed to cease use and to return the product to the firm.

Device

Device Recall XCaliber Ankle Complete Kit
  • Model / Serial
    Lot Numbers: IT956155 and IT967331
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- TX, ND, NY, FL and CA.
  • Product Description
    Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. || Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
  • Manufacturer
    Orthofix Srl

Manufacturer

Orthofix Srl
  • Manufacturer Address
    Orthofix Srl, Via Delle Nazioni 9, Bussolengo (Verona) Italy
  • Manufacturer Parent Company (2017)
    Orthofix International Nv
  • Source
    USFDA