Events

Recall of Device Recall ORTHOFIX, Connector System, LARGE SET SCREW

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
    79498
  • Event Risk Class
    Class 2
  • Event Number
    Z-1364-2018
  • Event Initiated Date
    2018-02-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162481
  • 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
    Orthosis, cervical pedicle screw spinal fixation - Product Code NKG
  • Reason
    Orthofix is conducting a voluntary recall of the connector system large set screw (pn: 79-2002) with affected lot numbers 001 and 002, and small set screw (pn: 79-2003) with affected lot numbers 002, 003 and 004. through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. as a result, it is possible that (1) the set screw drive feature will not accept the set screw driver (pn: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
  • Action
    The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.

Device

Device Recall ORTHOFIX, Connector System, LARGE SET SCREW
  • Model / Serial
    UDI 18257200125364, Lot Numbers: O01 and O02
  • Product Classification
    Orthopedic Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    US
  • Product Description
    ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
  • 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